Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 10649111262913
• Version / Model: 06-1101
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 60803c89-5bba-4e79-8030-0926af93d050

Device Description

PINARD ALUMINUM FETOSCOPE

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDE	STETHOSCOPE, MANUAL	Cardiovascular	870.1875	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32659	Foetal stethoscope	A mechanical listening device that is used for listening to foetal heart sounds. It is typically designed as a hollow tube (trumpet-shaped) to transmit the foetal heart sound through the inner channel by air conduction and is pressed against the outside of the mother's abdomen and the user will place their head and ear to the listening end of the device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10649111262913	GS1