Aesculap

FDA UDI

Class I (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name: AESCULAP FDA UDI
Generic Name: Scalpel, reusable FDA UDI
Device Name: KOOS Vessel Knife micro, curved upwards, 7 1/4" (185 mm), bayonet-shaped, sharp, round handle FDA UDI
Model / Reference: FD351R FDA UDI
Description: KOOS Vessel Knife micro, curved upwards, 7 1/4" (185 mm), bayonet-shaped, sharp, round handle FDA UDI

Identifiers

Catalog Number: FD351R FDA UDI
Primary DI / UDI-DI: 04038653160549 FDA UDI
FDA Product Code: EMF FDA UDI
GMDN Term: Scalpel, reusable 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: Scalpel, reusable

Aesculap by Aesculap, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Scalpel, reusable.

Knife, Bayonet Handle, Sharp Tip, Curved Up, 240mm — KATALYST SURGICAL, LLC · Class I
gSource — GSOURCE, LLC. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Integra® Ruggles®-Redmond™ — Integra LifeSciences Production Corporation · Class I
LAZIC — Peter Lazic GmbH · Class I
Arthroscopy hand instruments — SOPRO-COMEG GmbH · Class II
LAZIC — Peter Lazic GmbH · Class I
gSource — GSOURCE, LLC. · 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: Aesculap, Inc.

Sources (1)

FDA UDI 0da43fc1-4adf-4139-b79b-19188dd60091 35 fields · synced May 30, 2026