Atlas Choice Cranial Pattie Collection

GUDID 00749915002944

Atlas Choice Cranial Pattie Collection

AMERICAN SURGICAL COMPANY, LLC

Neurosurgical sponge

• Primary Device ID: 00749915002944
• NIH Device Record Key: 6b23e56e-f2a3-4fa9-90a3-45efed449fbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atlas Choice Cranial Pattie Collection
• Version Model Number: 300-01
• Company DUNS: 151054954
• Company Name: AMERICAN SURGICAL COMPANY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00749915002944 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-17
• Device Publish Date: 2021-12-09

Devices Manufactured by AMERICAN SURGICAL COMPANY, LLC

• 00749915002937 - Atlas Choice Microsurgery Pattie Collection: 2021-12-17 Atlas Choice Microsurgery Pattie Collection
• 00749915002944 - Atlas Choice Cranial Pattie Collection: 2021-12-17Atlas Choice Cranial Pattie Collection
• 00749915002944 - Atlas Choice Cranial Pattie Collection: 2021-12-17 Atlas Choice Cranial Pattie Collection
• 10749915002842 - Tapered Delicot: 2021-09-03 Tapered Delicot 6 mm x 19 mm x 51 mm
• 10749915002866 - Tapered Delicot: 2021-09-03 Tapered Delicot 6 mm x 19 mm x 51 mm
• 10749915002880 - Tapered Delicot: 2021-09-03 Tapered Delicot 19 mm x 25 mm x 25 mm
• 10749915002903 - Tapered Delicot: 2021-09-03 Tapered Delicot 19 mm x 25 mm x 76 mm
• 20749915002733 - Tapered Delicot: 2021-06-09 Tapered Delicot 3 mm x 6 mm x 48 mm
• 10749915002767 - Tapered Delicot: 2021-06-09 Tapered Delicot 4 mm x 9 mm x 48 mm