Circumplast

Basic Information

• Brand Name: Circumplast
• Primary DI: 09351108000029
• Version / Model: Circumplast 12mm
• Catalog Number: CIRC12MM
• Company Name: EMBOSS MEDICAL LIMITED
• Labeler DUNS: 226185194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-10-25
• Public Version: 5
• Public Version Date: 2021-02-09
• Public Version Status: Update
• Public Device Record Key: 9bfca599-fecc-4929-b40b-2812aeb5fd26
• Distribution End Date: 2050-10-25

Device Description

Circumplast single use infant male circumcision device, size 12mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HFX	Clamp, Circumcision	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38523	Surgical penis clamp, single-use	A sterile, hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09351108000029	GS1
Unit of Use	09351108000111	GS1