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Trephine

FDA UDI

Class I (US FDA UDI)

by KLS-Martin L.P.

Identity

Trade Name
TREPHINE FDA UDI
Generic Name
Orthopaedic bur, reusable FDA UDI
Device Name
BONE BIOPSY, CHAMPY, 21 MM INNER/23 MM OUTER DIAMETER FDA UDI
Model / Reference
23-190-06-07 FDA UDI
Description
BONE BIOPSY, CHAMPY, 21 MM INNER/23 MM OUTER DIAMETER FDA UDI

Identifiers

Primary DI / UDI-DI
00888118116635 FDA UDI
FDA Product Code
HWK FDA UDI
GMDN Term
Orthopaedic bur, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bur, reusable

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

Similar devices

Also classified as Orthopaedic bur, reusable.

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 e00d78c4-f7a9-40e8-b38e-72df720dc739 35 fields · synced May 29, 2026