Lithotomy Drape

FDA UDI

Class II (US FDA UDI)

by PROCEPT BioRobotics Corporation

Identity

Trade Name: Lithotomy Drape FDA UDI
Generic Name: Patient surgical drape, single-use FDA UDI
Model / Reference: FG351101 FDA UDI

Identifiers

Catalog Number: FG351101 FDA UDI
Primary DI / UDI-DI: 00860009122932 FDA UDI
FDA Product Code: EYY FDA UDI
GMDN Term: Patient surgical drape, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Patient surgical drape, single-use

Lithotomy Drape by PROCEPT BioRobotics Corporation — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: PROCEPT BioRobotics Corporation

Sources (1)

FDA UDI cf470c15-abb7-44ba-b91a-74adaabd7755 35 fields · synced May 30, 2026