PlastiBell Circumcision Device

FDA UDI

Class II (US FDA UDI)

by Aspen Surgical Products, Inc.

Identity

Trade Name: PlastiBell Circumcision Device FDA UDI
Generic Name: Surgical penis clamp, single-use FDA UDI
Device Name: 1.1 cm PlastiBell Circumcision Device FDA UDI
Model / Reference: 9231 FDA UDI
Description: 1.1 cm PlastiBell Circumcision Device FDA UDI

Identifiers

Primary DI / UDI-DI: 00840113231621 FDA UDI
FDA Product Code: FHG FDA UDI
GMDN Term: Surgical penis clamp, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4530 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

Yes

FDA UDI

Category: Surgical penis clamp, single-use

PlastiBell Circumcision Device by Aspen Surgical Products, Inc. — 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: Aspen Surgical Products, Inc.

Sources (1)

FDA UDI 80849327-11bd-42f2-9df1-b7bb03380cec 33 fields · synced Jun 9, 2026