Sklar

Basic Information

• Brand Name: Sklar
• Primary DI: 30649111365564
• Version / Model: 10-1672
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2019-03-19
• Public Version: 1
• Public Version Date: 2019-03-27
• Public Version Status: New
• Public Device Record Key: 9bacab5f-b97d-4752-bccb-2368692c2741

Device Description

CANNULA CLN BRUSH 15 INCHES25MM PK24

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNL	ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58718	Tracheostomy tube cannula cleaning swab, non-sterile	A non-sterile device intended to be used to clean the inner cannula of a tracheostomy tube that has been removed from the in situ tracheostomy tube. It typically consists of a flexible shaft, which in itself can act as a handle, with a swab made of foam or bristles at the distal end. It is used by a patient or healthcare provider to remove secretions from the inside of the inner cannula. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30649111365564	GS1
Unit of Use	00649111365563	GS1