Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 50649111400887
• Version / Model: 96-2582M
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-10-24
• Public Version: 4
• Public Version Date: 2021-01-08
• Public Version Status: Update
• Public Device Record Key: e8aefddc-7275-44f7-96cd-fdd065ada4c1

Device Description

DERF NH SERR 4 3/4" STERL CS50

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HXK	HOLDER, NEEDLE; ORTHOPEDIC	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47568	Suturing needle holder, single-use	A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50649111400887	GS1
Unit of Use	00649111400882	GS1