Cylindrical Sponge

GUDID 20749915001651

Cylindrical Sponges-Strung 3/8" x 1.5"

AMERICAN SURGICAL COMPANY, LLC

Dissection sponge

• Primary Device ID: 20749915001651
• NIH Device Record Key: 1e77dc7f-d01f-4753-ad1e-564ccd0daf57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cylindrical Sponge
• Version Model Number: 70-01
• Company DUNS: 151054954
• Company Name: AMERICAN SURGICAL COMPANY, LLC
• Device Count: 50
• 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	10749915001654 [Unit of Use]
GS1	20749915001651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872810

FDA Product Code

• EFN: Cotton, Roll

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 [Cylindrical Sponge]

• 20749915002481: Cylindrical Sponges-Strung 3/8" x 3/4"
• 20749915001668: Cylindrical Sponges-Strung 1/2" x 1.5"
• 20749915001651: Cylindrical Sponges-Strung 3/8" x 1.5"