Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Manual surgical saw, rigid FDA UDI
Device Name: Gigli saw handle, t-shaped with snap lock, sold as a pair FDA UDI
Model / Reference: Gigli saw handle FDA UDI
Description: Gigli saw handle, t-shaped with snap lock, sold as a pair FDA UDI

Identifiers

Catalog Number: 44-850 FDA UDI
Primary DI / UDI-DI: 00190660110031 FDA UDI
FDA Product Code: GDR FDA UDI
GMDN Term: Manual surgical saw, rigid FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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: Manual surgical saw, rigid

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

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LINDEMANN AMPUTATION SAW — SONTEC INSTRUMENTS, INC. · Class I
V. Mueller — STERIS CORPORATION · Class I
Intramedullary Bone Saw — Biomet Orthopedics, Inc. · Class I
Novo Surgical — NOVO 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

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Manufacturer

Manufacturer: Ambler Surgical, LLC

Sources (1)

FDA UDI e53f5d40-6a5e-48c6-867d-01ff295e419a 35 fields · synced Jun 6, 2026