Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10080196301904
• Version / Model: MDS10781
• Catalog Number: MDS10781
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6ae170b8-25ae-4dab-b9fc-9be024c23e5d

Device Description

CLAMP,CIRCUMCISION,1.3CM,NONSTERILE

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
38525	Circumcision clamp, single-use	A sterile, hand-held manual surgical instrument designed for the controlled removal of the foreskin of the penis during circumcision. It is typically made of metal and/or plastic materials and can have various designs, e.g., the Bell clamp. The foreskin is pushed over the bell-shaped protection rod and the glans placed into it. A screw mechanism is tightened so that the foreskin is annular compressed and is cut-off using, e.g., a scalpel, following the compression ring. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10080196301904	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K040052	000