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TBS PTFE membrane

FDA UDI

Class II (US FDA UDI)

by PURGO BIOLOGICS Inc.

Identity

Trade Name
TBS PTFE membrane FDA UDI
Generic Name
Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI
Model / Reference
TBSRGN08 FDA UDI

Identifiers

Primary DI / UDI-DI
08800039006682 FDA UDI
510(k) Number
K222549 FDA UDI
FDA Product Code
NPK 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

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

TBS PTFE membrane by PURGO BIOLOGICS 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
PURGO BIOLOGICS Inc.

Sources (1)

  • FDA UDI 2f1c88a8-cd57-457e-a01a-dc9819926f02 33 fields · synced May 30, 2026