Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 10649111197376
• Version / Model: 92-1014
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-01
• Public Version: 4
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 08187649-9ef5-49f0-8cab-b171144c99bc

Device Characteristics

• Single Use: No
• 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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HDA	Forceps, obstetrical	Obstetrics/Gynecology	884.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35082	Obstetrical forceps, reusable	A scissors-like obstetrical instrument intended specifically to assist the birth of the foetus during difficult vaginal births. It typically is designed with two curved blades are that are introduced separately and then connected to a handle to exert traction on the foetal head or to rotate the foetal head in order to facilitate its passage through the birth canal. It is made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10649111197376	GS1

Premarket Submissions

Submission Number	Supplement Number
K092827	000