Ultracot

GUDID 20749915000494

Ultracot 10 mm x 80 mm

AMERICAN SURGICAL COMPANY, LLC

Cottonoid pad

• Primary Device ID: 20749915000494
• NIH Device Record Key: 7ecd233c-6784-4c8f-930c-262094ff8dba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultracot
• Version Model Number: 23-18
• 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	10749915000497 [Unit of Use]
GS1	20749915000494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854713

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: 2016-06-06

On-Brand Devices [Ultracot ]

• 20749915000500: Ultracot 70 mm x 100 mm
• 20749915000494: Ultracot 10 mm x 80 mm
• 20749915000487: Ultracot 20 mm x 50 mm
• 20749915000470: Ultracot 30 mm x 90 mm
• 20749915000463: Ultracot 15 mm x 15 mm
• 20749915000456: Ultracot 30 mm x 70 mm
• 20749915000449: Ultracot 20 mm x 60 mm
• 20749915000432: Ultracot 13 mm x 60 mm
• 20749915000425: Ultracot 9 mm x 50 mm
• 20749915000418: Ultracot 6 mm x 50 mm
• 20749915000401: Ultracot 4 mm x 50 mm
• 20749915000395: Ultracot 15 mm x 20 mm
• 20749915000388: Ultracot 10 mm x 13 mm
• 20749915000371: Ultracot 5 mm x 13 mm
• 20749915000364: Ultracot 5 mm x 8 mm