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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, 1 QUADRANT, PREPROSTHETIC, MUA, LP, TI-6AL-4V FDA UDI
Model / Reference
60-004-43-09-LP FDA UDI
Description
IMPLANT, 1 QUADRANT, PREPROSTHETIC, MUA, LP, TI-6AL-4V FDA UDI

Identifiers

Primary DI / UDI-DI
00888118141866 FDA UDI
FDA Product Code
ELE FDA UDI
GMDN Term
Custom-made cranial bone prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3645 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
MRI Safety
MR Conditional 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 6fabfff1-5fc2-4c61-90e6-1a5e61cfd525 34 fields · synced Jun 8, 2026