Clip Gun

Basic Information

• Brand Name: Clip Gun
• Primary DI: 20643169109111
• Version / Model: CG8901
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Labeler DUNS: 089055867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-06-13
• Public Version: 4
• Public Version Date: 2023-11-15
• Public Version Status: Update
• Public Device Record Key: f4ce0764-41a1-43de-96f8-c8963f10a69a

Device Description

KIT CG8901 CLIP GUN 10 PK

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBO	CLIP, SCALP	Neurology	882.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46952	Scalp clip applier, single-use	A hand-held, manually-operated, surgical instrument used for the application (the attachment) of nonimplantable, single-use scalp clips to the margins of a scalp wound/incision during a surgical intervention on the cranium/scalp. Often referred to as a clip gun, it has a pistol-like design and holds an exchangeable, preloaded cassette of scalp clips that are fired into the scalp tissue, with the pull of a trigger, to approximate the margins of the wound/incision until it heals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20643169109111	GS1
Unit of Use	00643169109117	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050044	000
K896723	000