Prokera®

by BioTissue Holdings Inc.

Prokera® (PK-16) is a Class II device made by BioTissue Holdings Inc., listed in FDA GUDID since 5 Aug 2016 (UDI-DI 00855928005121), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00855928005121 UDI-DI	Date5 Aug 2016Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00855928005121

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name: Ophthalmic conformer
Model / Ref / Catalog: PROKERA®, PK-16

Primary DI / UDI-DI: 00855928005121
FDA product code: NQB
GMDN term: Ophthalmic conformer

Device class: Class II
Regulation number: 886.3130
GUDID distribution status: In Commercial Distribution

Other devices from BioTissue Holdings Inc.

Properties

Single use
Prescription use
HCT/P
Serial number
Expiration date

Other properties (10, all answered No)