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Htr-Pekk

FDA UDI

Class II (US FDA UDI)

by Oxford Performance Materials

Identity

Trade Name
HTR-PEKK FDA UDI
Generic Name
Custom-made cranial bone prosthesis FDA UDI
Model / Reference
PK623708-A FDA UDI

Identifiers

Primary DI / UDI-DI
00810023927686 FDA UDI
510(k) Number
K121818 FDA UDI
FDA Product Code
GXN FDA UDI
GMDN Term
Custom-made cranial bone prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5330 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Htr-Pekk by Oxford Performance Materials — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K121818 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oxford Performance Materials

Sources (1)

  • FDA UDI e2fd227e-60a6-4912-9f16-13918e64b350 35 fields · synced May 30, 2026