AccessGUDID - DEVICE: Derma (00809958000328)

GUDID

Device Identifier (DI) Information

Brand Name: Derma
Version or Model: 9004X
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DUP9004X
Company Name: Derma Sciences Canada Inc

Primary DI Number: 00809958000328
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 200564891 *Terms of Use

Device Description: 2 in X 100 yards, X-Ray detectable surgical gauze packing, made from 28 X 24 mesh gauze, 4-Ply.

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):	No
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?
48128	Gauze strip, non-antimicrobial	A thin length of non-medicated woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with medication (not included) before application. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDY	GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

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: No
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
Device Size Text, specify: 2 in X 100 yards
Device Size Text, specify: 5.08 cm X 91.4 m

Device Record Status

Public Device Record Key: a8395f78-3ab4-4213-a8b7-dde325b9ba14
Public Version Date: June 25, 2024
Public Version Number: 4
DI Record Publish Date: October 23, 2018