PROKERA®

Primary DI: 00855928005121
Brand: PROKERA®
Company: BioTissue Holdings Inc.
Model: PROKERA®
Catalog number: PK-16
Device description: PROKERA® CLASSIC Biologic Corneal Bandage
Published: 2016-08-05
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Single use: true

Product Codes#

Code, Name table
Code	Name
NQB	Conformer, Ophthalmic, Biological Tissue

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
NQB	Conformer, Ophthalmic, Biological Tissue	Ophthalmic	2

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00855928005121	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00855928005121	00855928005121	855928005121	0855928005121

GMDN Terms#

Term, Definition table
Term	Definition
Ophthalmic conformer	An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 167232888
Device count: 1
HCT/P: true
Serial number: true
Expiration date on label: true
Donation ID number: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00855928005138	PROKERA®	PROKERA® SLIM	PKS	2016-08-05
00855928005145	PROKERA®	PROKERA® PLUS	PKP	2016-08-05
00855928005442	PROKERA®	PROKERA® CLEAR	PKCLR	2016-08-05

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00855928005138	PROKERA®	BioTissue Holdings Inc.	NQB	2016-08-05
00855928005145	PROKERA®	BioTissue Holdings Inc.	NQB	2016-08-05
00855928005442	PROKERA®	BioTissue Holdings Inc.	NQB	2016-08-05