Circumplast

FDA UDI

Class II (US FDA UDI)

by Emboss Medical Limited

Identity

Trade Name: Circumplast FDA UDI
Generic Name: Circumcision clamp, single-use FDA UDI
Device Name: Circumplast single use infant male circumcision device, size 11mm FDA UDI
Model / Reference: Circumplast 11mm FDA UDI
Description: Circumplast single use infant male circumcision device, size 11mm FDA UDI

Identifiers

Catalog Number: CIRC11MM FDA UDI
Primary DI / UDI-DI: 09351108000012 FDA UDI
510(k) Number: K151095 FDA UDI
FDA Product Code: HFX FDA UDI
GMDN Term: Circumcision 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Circumcision clamp, single-use

Circumplast by Emboss Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circumcision clamp, single-use.

Medline — MEDLINE INDUSTRIES, INC. · Class II
Gomco Type Circumcision Clamp — FINE SURGICAL INSTRUMENTS INC. · Class II
AccuCirc® — Clinical Innovations, LLC · Class II
AccuCirc® — Clinical Innovations, LLC · Class II
Gomco Type Circumcision Clamp — FINE SURGICAL INSTRUMENTS INC. · Class II
Gomco Type Circumcision Clamp — FINE SURGICAL INSTRUMENTS INC. · Class II
AccuCirc® — Clinical Innovations, LLC · Class II
Medical Action Industries — MEDICAL ACTION INDUSTRIES INC. · Class II

Cleared under the same submission

K151095 also covers:

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: Emboss Medical Limited

Sources (1)

FDA UDI 2ffab4e9-1f1f-4c24-9854-d11e738e7e9b 36 fields · synced May 31, 2026