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Cytoplast™ Non-Resorbable PTFE Barrier Membranes

FDA UDI

Class II (US FDA UDI)

by Osteogenics Biomedical, Inc.

Identity

Trade Name
Cytoplast™ Non-Resorbable PTFE Barrier Membranes FDA UDI
Generic Name
Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI
Device Name
Nonresorbable PTFE Barrier Membrane, 12 mm x 24 mm FDA UDI
Model / Reference
GBR1224 FDA UDI
Description
Nonresorbable PTFE Barrier Membrane, 12 mm x 24 mm FDA UDI

Identifiers

Primary DI / UDI-DI
D765GBR12240 FDA UDI
FDA Product Code
LYC FDA UDI
GMDN Term
Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3930 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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 — 24 Millimeter FDA UDI
Width — 12 Millimeter FDA UDI

Category: Pliable-polymer dental regeneration membrane, non-bioabsorbable

Cytoplast™ Non-Resorbable PTFE Barrier Membranes by Osteogenics Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pliable-polymer dental regeneration membrane, non-bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osteogenics Biomedical, Inc.

Sources (1)

  • FDA UDI 775e6e20-1ef4-4c06-9d14-18c0e95c0b7d 35 fields · synced Jun 1, 2026