N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00721902371592
• Version / Model: CL8903
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Labeler DUNS: 089055867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-09-12
• Public Version: 1
• Public Version Date: 2020-09-21
• Public Version Status: New
• Public Device Record Key: db2f8561-d0c8-4b23-9f05-7a20d0e4d27f

Device Description

CLIPS CL8903 RANEY 10 JPN

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
46953	Scalp wound clip	A small, nonimplantable device in the form of a U-shaped clip that is fired from a dedicated scalp-clip applier (clip gun) or manually applied using dedicated scalp clip forceps, to approximate the margins of a scalp wound/incision associated with a surgical intervention on the cranium/scalp. It is made of metal or plastic materials and is typically applied in rows; it is intended to remain in place until the incision has healed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	70721902371591	GS1
Primary	00721902371592	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050044	000