Tonsil Sponges

GUDID 20749915000760

Tonsil Sponges 1.25" X-Large

AMERICAN SURGICAL COMPANY, LLC

Dissection sponge

• Primary Device ID: 20749915000760
• NIH Device Record Key: 49c9db91-408d-4860-a4e0-a9c11687372c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tonsil Sponges
• Version Model Number: 50-02
• Company DUNS: 151054954
• Company Name: AMERICAN SURGICAL COMPANY, LLC
• Device Count: 40
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10749915000763 [Unit of Use]
GS1	20749915000760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872806

FDA Product Code

• EFQ: Gauze/Sponge, Internal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-30

On-Brand Devices [Tonsil Sponges]

• 20749915000760: Tonsil Sponges 1.25" X-Large
• 20749915000753: Tonsil Sponges 1" Large
• 20749915000746: Tonsil Sponges 3/4" Medium