Aesclepius Locking Clamp, Standard

FDA UDI

Class I (US FDA UDI)

by Aesclepius Corporation

Identity

Trade Name: Aesclepius Locking Clamp, Standard FDA UDI
Generic Name: Bone approximation clamp FDA UDI
Device Name: Single stainless steel locking bone clamp surgical instrument, standard size FDA UDI
Model / Reference: AESC-1001 FDA UDI
Description: Single stainless steel locking bone clamp surgical instrument, standard size FDA UDI

Identifiers

Primary DI / UDI-DI: G485AESC10010 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Bone approximation clamp 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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable Bone approximation clamp

Aesclepius Locking Clamp, Standard by Aesclepius Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone approximation clamp.

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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

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Manufacturer

Manufacturer: Aesclepius Corporation

Sources (1)

FDA UDI 5c51f272-a06d-4026-a39e-ec43608d4edc 34 fields · synced May 30, 2026