SCALPFIX

Basic Information

• Brand Name: SCALPFIX
• Primary DI: 04038653222841
• Version / Model: FF012R
• Catalog Number: FF012R
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-23
• Public Version: 1
• Public Version Date: 2020-05-01
• Public Version Status: New
• Public Device Record Key: 77b5c40a-0b3a-4671-91cf-a5db9c760956

Device Description

SCALPFIX APPLICATOR

Device Characteristics

• Single Use: No
• 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: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDO	Applier, surgical, clip	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46951	Scalp clip applier, reusable	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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04038653222841	GS1

Customer Contacts

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