Tapered Delicot

GUDID 10749915002811

Tapered Delicot 9 mm x 13 mm x 76 mm

AMERICAN SURGICAL COMPANY, LLC

Neurosurgical sponge

• Primary Device ID: 10749915002811
• NIH Device Record Key: 682282f0-0576-4b3e-88f7-f1ff3dc9ba99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tapered Delicot
• Version Model Number: 63-11T
• 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	00749915002807 [Primary]
GS1	10749915002811 [Unit of Use]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-09
• Device Publish Date: 2021-06-01

On-Brand Devices [Tapered Delicot]

• 10749915002668: Tapered Delicot 2 mm x 4 mm x 48 mm
• 10749915002828: Tapered Delicot 8 mm x 19 mm x 76 mm
• 10749915002811: Tapered Delicot 9 mm x 13 mm x 76 mm
• 10749915002781: Tapered Delicot 8 mm x 19 mm x 64 mm
• 10749915002767: Tapered Delicot 4 mm x 9 mm x 48 mm
• 20749915002733: Tapered Delicot 3 mm x 6 mm x 48 mm
• 10749915002903: Tapered Delicot 19 mm x 25 mm x 76 mm
• 10749915002880: Tapered Delicot 19 mm x 25 mm x 25 mm
• 10749915002866: Tapered Delicot 6 mm x 19 mm x 51 mm
• 10749915002842: Tapered Delicot 6 mm x 19 mm x 51 mm