Ambler Surgical

FDA UDI

Class II (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Laminectomy retractor, self-retaining FDA UDI
Device Name: McCulloch-type microdisectomy retractor muscle blades, narrow pattern, 4 pair set includes 1 pair of 2.0cm x 4.0cm, 2.0cm x 5.0cm, 2.0cm x 6.0cm and 2.0cm x 7.0cm blades, titanium (72-544, 72-545, 72-546 and 72-547) FDA UDI
Model / Reference: 72-540 FDA UDI
Description: McCulloch-type microdisectomy retractor muscle blades, narrow pattern, 4 pair set includes 1 pair of 2.0cm x 4.0cm, 2.0cm x 5.0cm, 2.0cm x 6.0cm and 2.0cm x 7.0cm blades, titanium (72-544, 72-545, 72-546 and 72-547) FDA UDI

Identifiers

Catalog Number: 72-540 FDA UDI
Primary DI / UDI-DI: 00190660139544 FDA UDI
510(k) Number: K071771 FDA UDI
FDA Product Code: GZT FDA UDI
GMDN Term: Laminectomy retractor, self-retaining FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4800 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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: Laminectomy retractor, self-retaining

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

Similar devices

Also classified as Laminectomy retractor, self-retaining.

SeaSpine Spacer System - Pacifica — SeaSpine Orthopedics Corporation · Class I
Stealth Surgical — Boss Instruments, Ltd. · Class II
Stealth Surgical — Boss Instruments, Ltd. · Class II
Stealth Surgical — Boss Instruments, Ltd. · Class II
Ambler Surgical — Ambler Surgical, LLC · Class II
Ambler Surgical — Ambler Surgical, LLC · Class II
Ambler Surgical — Ambler Surgical, LLC · Class II
Ambler Surgical — Ambler Surgical, LLC · Class II

Cleared under the same submission

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 II	Pending data

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Manufacturer

Manufacturer: Ambler Surgical, LLC

Sources (1)

FDA UDI 3f0aec1a-ce69-4d2b-93f2-67248887639c 36 fields · synced May 30, 2026