AccessGUDID - DEVICE: Dukal (10665973018017)

GUDID

Device Identifier (DI) Information

Brand Name: Dukal
Version or Model: 7205327 and 7206327 and 7260033
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7205327 and 7206327 and 7260033
Company Name: Dukal LLC

Primary DI Number: 10665973018017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791014871 *Terms of Use

Device Description: Non-Woven Pad 2" x 2" 4-Ply, Sterile

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":	Yes
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?
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAB	Gauze / sponge,nonresorbable for external use

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1d7e55f5-a970-4174-bfcf-2f4bf8f3098c
Public Version Date: December 10, 2024
Public Version Number: 3
DI Record Publish Date: December 02, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20665973018014	10	10665973018017	In Commercial Distribution	Box
70665973018019	12	60665973018012	In Commercial Distribution	Case
60665973018012	100	10665973018017	In Commercial Distribution	Box
50665973018015	24	40665973018018	In Commercial Distribution	Case
40665973018018	25	10665973018017	In Commercial Distribution	Box
30665973018011	36	20665973018014	In Commercial Distribution	Case