Uniqcot

GUDID 20749915001354

Uniqcot 3/8" x 3"

AMERICAN SURGICAL COMPANY, LLC

Neurosurgical sponge

• Primary Device ID: 20749915001354
• NIH Device Record Key: 440e0824-b690-441d-96f6-6e908352f0ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uniqcot
• Version Model Number: 67-05
• Company DUNS: 151054954
• Company Name: AMERICAN SURGICAL COMPANY, LLC
• Device Count: 20
• 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	10749915001357 [Unit of Use]
GS1	20749915001354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902921

FDA Product Code

• HBA: Neurosurgical Paddie

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: 2016-06-14

On-Brand Devices [Uniqcot]

• 20749915001644: Uniqcot Strips 1.5" x 6"
• 20749915001637: Uniqcot Strips 3.5" x 6"
• 20749915001620: Uniqcot Strips 3" x 6"
• 20749915001613: Uniqcot Strips 2" x 6"
• 20749915001606: Uniqcot Strips 1" x 6"
• 20749915001590: Uniqcot Strips 3/4" x 6"
• 20749915001583: Uniqcot Strips 1/2" x 6"
• 20749915001576: Uniqcot Strips 1/4" x 6"
• 20749915001569: Uniqcot Strips 1/8" x 6"
• 20749915001552: Uniqcot 1/2" x 2"
• 20749915001545: Uniqcot 1.5" x 3"
• 20749915001538: Uniqcot 1/4" x 1.5"
• 20749915001521: Uniqcot 3" x 3"
• 20749915001514: Uniqcot 1.5" x 1.5"
• 20749915001491: Uniqcot 1" x 3"
• 20749915001477: Uniqcot 1" x 1"
• 20749915001453: Uniqcot 3/4" x 3/4"
• 20749915001439: Uniqcot 1/2" x 3"
• 20749915001408: Uniqcot 1/2" x 1.5"
• 20749915001385: Uniqcot 1/2" x 1"
• 20749915001361: Uniqcot 1/2" x 1/2"
• 20749915001354: Uniqcot 3/8" x 3"
• 20749915001347: Uniqcot 1/4" x 3"
• 20749915001330: Uniqcot 1/4" x 1/4"