Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10080196301898
• Version / Model: MDS10780
• Catalog Number: MDS10780
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 4
• Public Version Date: 2022-08-29
• Public Version Status: Update
• Public Device Record Key: 55416a32-eabc-401d-903e-6aef6859f4d1
• Distribution End Date: 2022-08-27

Device Description

CLAMP,CIRCUMCISION,1.1CM,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
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	10080196301898	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K040052	000