Americot

Basic Information

• Brand Name: Americot
• Primary DI: 20749915000258
• Version / Model: 20-31SW
• Company Name: AMERICAN SURGICAL COMPANY, LLC
• Labeler DUNS: 151054954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-06-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9f9a8b55-d95a-44e4-8ac9-06e311297455

Device Description

Americot White 1.5 cm x 5.5 cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBA	Neurosurgical Paddie	Neurology	882.4700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32572	Cottonoid pad	A cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20749915000258	GS1
Unit of Use	10749915000251	GS1

Premarket Submissions

Submission Number	Supplement Number
K854713	000