AccessGUDID - DEVICE: Sunmark (00010939593337)

GUDID

Device Identifier (DI) Information

Brand Name: Sunmark
Version or Model: B FMDLS 0130 R02401 SM
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: U.S. COTTON, LLC

Primary DI Number: 00010939593337
Issuing Agency: GS1
Commercial Distribution End Date: January 03, 2022
Device Count: 130
Labeler D-U-N-S® Number*: 932938897 *Terms of Use

Device Description: Sterile Cotton Balls (130ct Medium Size)

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?
63282	Cotton wool ball, sterile	A sterile, non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use to absorb fluids, typically in a surgical setting. It may be radiopaque to make it visible on x-ray, and may have an attached cord to improve traceability in a surgical setting. 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: 3a2aca90-13f0-4163-98bc-80642a380eca
Public Version Date: January 04, 2022
Public Version Number: 2
DI Record Publish Date: February 28, 2020