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Biopor®

FDA UDI

Class II (US FDA UDI)

by Ceremed , Inc.

Identity

Trade Name
Biopor® FDA UDI
Generic Name
Polyethylene craniofacial tissue reconstructive material FDA UDI
Device Name
Medium Malar Shell L FDA UDI
Model / Reference
CSL-4052 FDA UDI
Description
Medium Malar Shell L FDA UDI

Identifiers

Catalog Number
CSL-4052 FDA UDI
Primary DI / UDI-DI
CSL40520 FDA UDI
FDA Product Code
KKY FDA UDI
GMDN Term
Polyethylene craniofacial tissue reconstructive material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 49 Millimeter FDA UDI

Category: Polyethylene craniofacial tissue reconstructive material

Biopor® by Ceremed , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyethylene craniofacial tissue reconstructive material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ceremed , Inc.

Sources (1)

  • FDA UDI a1843b1b-8466-4756-8386-b2983c73a6d9 37 fields · synced May 31, 2026