Sklar

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar FDA UDI
Generic Name: Airway tube forceps, reusable FDA UDI
Device Name: TUBE OCC FCPS 41/2 INCHES,STR SMOOTH FDA UDI
Model / Reference: 97-589 FDA UDI
Description: TUBE OCC FCPS 41/2 INCHES,STR SMOOTH FDA UDI

Identifiers

Primary DI / UDI-DI: 10649111191404 FDA UDI
FDA Product Code: GEN FDA UDI
GMDN Term: Airway tube forceps, 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Airway tube forceps, reusable

Sklar by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Airway tube forceps, reusable.

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FENTEX — FENTEX medical GmbH · Class I
BR Surgical, LLC — BR SURGICAL LLC · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
Standard Tube Forceps 18cm — N S SURGICAL COMPANY · Class I
Grafco — GF Health Products, Inc · 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: Sklar Corporation

Sources (1)

FDA UDI 14dd1d52-0f88-47ff-a5d5-c38caf1c2c8f 33 fields · synced Jun 8, 2026