AccessGUDID - DEVICE: U.S. Cotton (00095859100162)

GUDID

Device Identifier (DI) Information

Brand Name: U.S. Cotton
Version or Model: L FZUSS 0160 R01201 US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: L FZUSS 0160 R01201 US
Company Name: U.S. COTTON, LLC

Primary DI Number: 00095859100162
Issuing Agency: GS1
Commercial Distribution End Date: August 19, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 932938897 *Terms of Use

Device Description: Sterile Cotton Roll (16 oz)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58233	Cotton wool roll, sterile	A device designed as an absorbent, sterile mass of cotton or man-made fibres formed in a continuous length (roll) and typically used as a general-purpose absorbent or padding within the healthcare sector; it is not in the form of a bandage or dedicated dressing. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FRL	Fiber, Medical, Absorbent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store indoors under normal ambient conditions in sealed package

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: db45519d-e29a-4511-9512-773e065a1e42
Public Version Date: September 21, 2022
Public Version Number: 2
DI Record Publish Date: February 28, 2020