Telfa

GUDID 30749915001764

Telfa 1" x 1"

AMERICAN SURGICAL COMPANY, LLC

Neurosurgical sponge

• Primary Device ID: 30749915001764
• NIH Device Record Key: 8bb72ad3-1aa5-478b-9474-f0d6e9e52d83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Telfa
• Version Model Number: 80-12
• 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	10749915001760 [Unit of Use]
GS1	30749915001764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904514

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: 2016-06-16

On-Brand Devices [Telfa]

• 30749915001764: Telfa 1" x 1"
• 20749915001835: Telfa Strips 1" x 6"
• 20749915001828: Telfa Strips 3/4" x 6"
• 20749915001811: Telfa Strips 1/2" x 6"
• 20749915001804: Telfa 1.5" x 3"
• 20749915001798: Telfa 3" x 3"
• 20749915001774: Telfa 1" x 3"
• 20749915001743: Telfa 3/4" x 3"
• 20749915001729: Telfa 1/2" x 3"
• 20749915001705: Telfa 1/2" x 1.5"
• 20749915001699: Telfa 1/2" x 1/2"
• 20749915001682: Telfa 3/8" x 3"
• 20749915001675: Telfa 1/4" x 3"