Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 30649111334263
• Version / Model: 24-1116
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-01-09
• Public Version: 1
• Public Version Date: 2019-02-11
• Public Version Status: New
• Public Device Record Key: 3c0b81b3-8d0b-4ce9-afb9-fa5ea54795a6

Device Description

WACHENFELDT WOUND CLIPS 16MM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
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
Primary	30649111334263	GS1
Unit of Use	00649111334262	GS1