Americot

GUDID 20749915000135

Americot Blue 3" x 3"

AMERICAN SURGICAL COMPANY, LLC

Cottonoid pad

• Primary Device ID: 20749915000135
• NIH Device Record Key: 250549e7-fcb9-4b35-8708-613e2b0921de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Americot
• Version Model Number: 20-12S
• 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	10749915000138 [Unit of Use]
GS1	20749915000135 [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: 2016-06-01

On-Brand Devices [Americot ]

• 40749915000207: Americot Blue 3/8" x 1"
• 30749915000316: Americot White 1" x 6"
• 30749915000224: Americot Blue 3/4" x 2"
• 20749915000357: Americot White 3.5" x 6"
• 20749915000340: Americot White 3" x 6"
• 20749915000333: Americot White 2" x 6"
• 20749915000326: Americot White 1.5" x 6"
• 20749915000302: Americot White 3/4" x 6"
• 20749915000296: Americot White 1/2" x 6"
• 20749915000289: Americot White 1/4" x 6"
• 20749915000272: Americot White 2" x 3"
• 20749915000265: Americot Blue 1/2" x 2"
• 20749915000258: Americot White 1.5 cm x 5.5 cm
• 20749915000241: Americot Blue 1/4" x 1.5"
• 20749915000234: Americot Blue 1/4" x 3"
• 20749915000210: Americot Blue 3/8" x 2"
• 20749915000203: Americot Blue 3/8" x 3/8"
• 20749915000180: Americot Blue 1/8" x 1/8"
• 20749915000173: Americot Blue 1 cm x 4 cm
• 20749915000166: Americot Blue 5/8" x 3/4"
• 20749915000159: Americot Blue 3/8" x 3/4"
• 20749915000142: Americot Blue 3/4" x 3"
• 20749915000135: Americot Blue 3" x 3"
• 20749915000128: Americot Blue 1.5" x 1.5"
• 20749915000111: Americot Blue 1" x 3"
• 20749915000104: Americot Blue 1" x 1"
• 20749915000081: Americot Blue 1/2" x 3"
• 20749915000074: Americot Blue 1/2" x 1.5"
• 20749915000067: Americot Blue 1/2" x 1"
• 20749915000050: Americot Blue 1/2" x 1/2"
• 20749915000036: Americot Blue 1/4" x 1/4"
• 00749915002654: Americot Blue 3/4" x 3/4" Non-Sterile
• 00749915002647: Americot Blue 1/2" x 1/2" Non Sterile
• 00749915002630: Americot Blue 1/2" x 1.5" Non Sterile
• 00749915002623: Americot Blue 3" x 3" Non Sterile
• 00749915002616: Americot Blue 1" x 3" Non Sterile
• 00749915002609: Americot Blue 1/2" x 3" Non Sterile
• 00749915002593: Americot Blue 1/2" x 1" Non Sterile