Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Bone lever/elevator, reusable FDA UDI
Device Name: Ambler elevator, 15'', slightly curved, 6.0mm x 19.0mm wide blade, round handle FDA UDI
Model / Reference: Ambler elevator FDA UDI
Description: Ambler elevator, 15'', slightly curved, 6.0mm x 19.0mm wide blade, round handle FDA UDI

Identifiers

Catalog Number: 20-116 FDA UDI
Primary DI / UDI-DI: 00190660203818 FDA UDI
FDA Product Code: KAD FDA UDI
GMDN Term: Bone lever/elevator, reusable 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 lever/elevator, reusable

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

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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 7ebb4cac-f666-4a3f-88b3-328dfd539598 35 fields · synced May 30, 2026