Delicot

GUDID 20749915001163

Delicot 10 mm x 13 mm

AMERICAN SURGICAL COMPANY, LLC

Neurosurgical sponge

• Primary Device ID: 20749915001163
• NIH Device Record Key: 3e05e299-c8ea-41be-9bcf-93b55098f412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delicot
• Version Model Number: 63-03
• 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	10749915001166 [Unit of Use]
GS1	20749915001163 [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: 2016-06-13

On-Brand Devices [Delicot ]

• 20749915001316: Delicot 30 mm x 70 mm
• 20749915001309: Delicot 20 mm x 60 mm
• 20749915001279: Delicot 13 mm x 60 mm
• 20749915001255: Delicot 9 mm x 50 mm
• 20749915001231: Delicot 6 mm x 50 mm
• 20749915001217: Delicot 4 mm x 50 mm
• 20749915001194: Delicot 15 mm x 20 mm
• 20749915001163: Delicot 10 mm x 13 mm
• 20749915001132: Delicot 5 mm x 13 mm
• 20749915001101: Delicot 5 mm x 8 mm