Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar® FDA UDI
Generic Name: Pylorus separator FDA UDI
Device Name: PAYR PYLORUS CLAMP W/PIN 11" FDA UDI
Model / Reference: 36-4311 FDA UDI
Description: PAYR PYLORUS CLAMP W/PIN 11" FDA UDI

Identifiers

Primary DI / UDI-DI: 10649111096839 FDA UDI
FDA Product Code: GEN FDA UDI
GMDN Term: Pylorus separator 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: Pylorus separator

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

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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 313a2466-e9c7-49b4-8d8b-fcc4711ab776 33 fields · synced May 30, 2026