Tonsil Sponges

Basic Information

• Brand Name: Tonsil Sponges
• Primary DI: 20749915000753
• Version / Model: 50-01
• Company Name: AMERICAN SURGICAL COMPANY, LLC
• Labeler DUNS: 151054954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f474b3e2-a684-4426-8e8a-e84c0b952098

Device Description

Tonsil Sponges 1" Large

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFQ	Gauze/Sponge, Internal	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
13698	Dissection sponge	A sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20749915000753	GS1
Unit of Use	10749915000756	GS1

Premarket Submissions

Submission Number	Supplement Number
K872806	000