Blade Scalpel

FDA UDI

Class I (US FDA UDI)

by Katena Products, Inc.

Identity

Trade Name: Blade Scalpel FDA UDI
Generic Name: Manual scalpel blade, single-use FDA UDI
Device Name: SCLEROTOME BLADE #57 (BX/5) FDA UDI
Model / Reference: K20-2457 FDA UDI
Description: SCLEROTOME BLADE #57 (BX/5) FDA UDI

Identifiers

Catalog Number: K20-2457 FDA UDI
Primary DI / UDI-DI: 00841668113462 FDA UDI
FDA Product Code: GES FDA UDI
GMDN Term: Manual scalpel blade, single-use 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

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Manual scalpel blade, single-use

Blade Scalpel by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual scalpel blade, single-use.

Paramount — Paramount Surgimed Limited · Class IIa
Bard-Parker ® Carbon Rib-Back Blades — Aspen Surgical Products, Inc. · Class I
Swann-Morton — Swann-Morton Ltd · Class IIa
SHARD — APPLIED DENTAL, INC. · Class I
Sterile Stainless Blades — Southmedic Incorporated · Class I
Paramount — Paramount Surgimed Limited · Class IIa
Swann-Morton — Swann-Morton Ltd · Class IIa
SHARD — APPLIED DENTAL, 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: Katena Products, Inc.

Sources (1)

FDA UDI 969415ef-8a5b-409d-9b47-199c271ad242 35 fields · synced Jun 12, 2026