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See Instructions for OMB Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 613012020 DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER 2. REASON FOR SUBMISSION VALIDATION--FOR FDA USE ONLY 1

PUBLIC HEALTH SERVICE (FDA Establishment Identifier) a. D INITIAL REGISTRATION I LISTING VALIDATED BY FDA:21-NOV-2017 FOOD AND DRUG ADMINISTRATION b. D ANNUAL REGISTRATION I LISTING DISTRICT: Dallas

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, FEI: 3009234552 c. 00 CHANGE IN INFORMATION

PRINTED BY FDA:27-JAN-2018 AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)

(See reverse side for instructions) d. D INACTIVE PART 1- ESTABLISHMENT INFORMATION PART II- PRODUCT INFORMATION C'le o:::o- me ;a ""m mm!'J ::Oin 3. OTHER FDA REGISTRATIONS 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT IPs -o h>::O 8cns;:

Establishment Functions ::ta; 14. PROPRIETARY a. BLOOD FDA 2830 NO. :...m em"' NAME(S) e>e me ,... e Types of HCT I Ps z e )lo

b. DEVICES FDA 2891 NO. Recover Screen Test Package Process Store Label Distribute C'lln ::0 (I) m c: (I) G') en c. DRUG FDA 2656 NO.

4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code) a. Bone X X X X X X X *** See full text on next pag<

CellRight Technologies b. Cartilage

1808 Universal City Blvd c. Cornea Universal City, Texas 78148 d. Dura Mater

0SIP e. Embryo 0 Directed

a. PHONE 210-659-9353 EXT 0 Anonymous b.o SATELLITE RECOVERY ESTABLISHMENT

f. Fascia X X X X X X X D(MANUFACTURING ESTABLISHMENT FEI NO. c. TESTING FOR MICRO-ORGANISMS ONLY

5. ENTER CORRECTIONS TO ITEM 4 g. Heart Valve

h. Ligament X X X X X X X

0 SIP 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, i. Oocyte 0 Directed number and street, city, state, country, and post office code) 0 Anonymous

Cel!Right Technologies j . Pericardium X X X X X X X Attn: Robin M. Sullivan, DC, CTBS

1808 Universal City Blvd k. Peripheral 0 Autologous Universal City, Texas 78148 Blood Stem 0 Family Related

0AIIogeneic

I. Sclera

OSIP a. PHONE 210-659-9353 EXT m. Semen 0 Directed 7. ENTER CORRECTIONS TO ITEM 6 0 Anonymous

b. PHONE X X X X X X X MatrixiQ Dermis, DermaPure n. Skin

o. Somatic Cell 0 Autologous Therapy 0 Family Related Products 0

8. U.S. AGENT p. Tendon X X X X X X X

q. Umbilical Cord Blood 0 Family Related

0AIIogeneic

a. E-MAIL r. Vascular Graft

s. Amniotic Membrane X X X X X X X

. 07ff t. a. TYPED NAME Robin M. Sullivan, DC, CTBS b. E-MAIL rsullivan@cellrighttechnologies.com

u.

c. TITLE VP of Regulatory Affairs d. DATE 21-NOV-2017 v.

FORM FDA • 3356 (7/17)

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for instructions)

ADDITIONAL INFORMATION:

Proprietary Name(s): a. Bone MatrixOI, FlexiT, Influx, MatrixCellect I 00 DBM

Putty, MatrixCellect I 00 DBM Crunch, ConCelltrate 100, Denta!Fix

FORM FDA - 3356 (7/17)

1. REGISTRATION NUMBER (FDA Establishment Identifier)

FEI: 3009234552

See Instructions for OMS Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 6/30/2020

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