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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 organ/bone anatomy model/surgical guide kit FDA UDI
Device Name
CUTTING GUIDE, CRANIAL, SUPPLEMENTAL FDA UDI
Model / Reference
60-004-50-09 FDA UDI
Description
CUTTING GUIDE, CRANIAL, SUPPLEMENTAL FDA UDI

Identifiers

Primary DI / UDI-DI
00888118136190 FDA UDI
FDA Product Code
PPT FDA UDI
GMDN Term
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

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 organ/bone anatomy model/surgical guide kit

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 organ/bone anatomy model/surgical guide kit.

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 46c3e258-0f92-44d5-a8eb-a1ef15a14aef 34 fields · synced May 30, 2026