NA

Basic Information

• Brand Name: NA
• Primary DI: 00643169647176
• Version / Model: CG8900
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Labeler DUNS: 089055867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-13
• Public Version: 4
• Public Version Date: 2019-03-14
• Public Version Status: Update
• Public Device Record Key: ae5bc4e1-dd34-436f-994a-84dfa4d3a6d0

Device Description

GUN CG8900 RANEY CLIP KIT 1PK

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	00643169647176	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050044	000