Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Bone approximation clamp FDA UDI
Device Name: Rowe maxillary disimpaction forceps, 9 1/2'', left narrow blade FDA UDI
Model / Reference: Rowe maxillary disimpaction forceps FDA UDI
Description: Rowe maxillary disimpaction forceps, 9 1/2'', left narrow blade FDA UDI

Identifiers

Catalog Number: 33-216 FDA UDI
Primary DI / UDI-DI: 00190660072278 FDA UDI
FDA Product Code: KAE FDA UDI
GMDN Term: Bone approximation clamp FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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 approximation clamp

Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone approximation clamp.

Journey II — Smith & Nephew, Inc. · Class II
PERI-LOC VLP — Smith & Nephew, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class I
Bone Clamp — Koros USA, Inc. · Class I
PROFIX — Smith & Nephew, Inc. · Class II
Sklar® — Sklar Corporation · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
Symmetry Martin — SYMMETRY SURGICAL 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: Ambler Surgical, LLC

Sources (1)

FDA UDI 361e91b0-8c8f-46b8-a417-a854f57f7081 35 fields · synced Jun 1, 2026