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Ips

FDA UDI

Class II (US FDA UDI)

by KLS-Martin L.P.

Identity

Trade Name
IPS FDA UDI
Generic Name
Custom-made cranial bone prosthesis FDA UDI
Device Name
IMPLANT, MIDFACE, 00028, LP, PEEK FDA UDI
Model / Reference
60-000-28-09-LP FDA UDI
Description
IMPLANT, MIDFACE, 00028, LP, PEEK FDA UDI

Identifiers

Primary DI / UDI-DI
00888118140173 FDA UDI
FDA Product Code
GXP FDA UDI
GXN FDA UDI
GMDN Term
Custom-made cranial bone prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5300 FDA UDI
882.5330 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made cranial bone prosthesis

Ips by KLS-Martin L.P. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made cranial bone prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
KLS-Martin L.P.

Sources (1)

  • FDA UDI cf6f98bc-bf6a-4ad9-81a8-d57f822a7667 34 fields · synced May 30, 2026