Empire Surgical Instruments Company

FDA UDI

Class I (US FDA UDI)

by Empire Surgical Instruments Company

Identity

Trade Name: EMPIRE SURGICAL INSTRUMENTS COMPANY FDA UDI
Generic Name: General-purpose surgical scissors, single-use FDA UDI
Device Name: IRIS SCISSORS 4.5" STR PP FDA UDI
Model / Reference: 11-138-PP FDA UDI
Description: IRIS SCISSORS 4.5" STR PP FDA UDI

Identifiers

Catalog Number: 11-138-PP FDA UDI
Primary DI / UDI-DI: B92311138PP1 FDA UDI
FDA Product Code: LRW FDA UDI
GMDN Term: General-purpose surgical scissors, 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Ethylene Oxide FDA UDI

Category: General-purpose surgical scissors, single-use

Empire Surgical Instruments Company by Empire Surgical Instruments Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose surgical scissors, single-use.

Bioseal Inc. — BIOSEAL · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Sklar — Sklar Corporation · Class I
Centurion — Centurion Medical Products · Class I
Sklar® — Sklar Corporation · Class I
Bioseal Inc. — BIOSEAL · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Sklar — Sklar Corporation · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Empire Surgical Instruments Company

Sources (1)

FDA UDI 1218bcb1-bd96-4773-8d48-270a7dea1307 35 fields · synced May 30, 2026