Level One Transbuccal

FDA UDI

Class I (US FDA UDI)

by KLS-Martin L.P.

Identity

Trade Name: LEVEL ONE TRANSBUCCAL FDA UDI
Generic Name: Bone-resection orthopaedic reamer, single-use FDA UDI
Device Name: COUNTERSINK, LAG, FOR 50-317-00-07 FDA UDI
Model / Reference: 50-320-00-07 FDA UDI
Description: COUNTERSINK, LAG, FOR 50-317-00-07 FDA UDI

Identifiers

Primary DI / UDI-DI: 00888118074980 FDA UDI
FDA Product Code: HWW FDA UDI
GMDN Term: Bone-resection orthopaedic reamer, single-use 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone-resection orthopaedic reamer, single-use

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

Similar devices

Also classified as Bone-resection orthopaedic reamer, single-use.

RAZOR Single-Use Acetabular Reamer — Razor Medical Instruments, Inc. · Class I
RAZOR Single-Use Acetabular Reamer — Razor Medical Instruments, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
Disposable — Biomet Orthopedics, Inc. · Class I
PANTA® — Newdeal Sas · Class I
ACETABULAR REAMER EVO 2 Ti CUP D42 mm — HPF SRL · Class I
Arthrex® — Arthrex, Inc. · Class I
Tools - UFC — Trimed, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: KLS-Martin L.P.

Sources (1)

FDA UDI 12c583b1-8f35-47f5-ade7-f08f8f921860 34 fields · synced Jun 6, 2026