AccessGUDID - DEVICE: DuCare® (00809958185810)

GUDID

Device Identifier (DI) Information

Brand Name: DuCare®
Version or Model: 82815H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DUP82815H
Company Name: Derma Sciences Canada Inc

Primary DI Number: 00809958185810
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 200564891 *Terms of Use

Device Description: H-fold 8 in X 4 in, 12 ply, 20 X 10 mesh Premium gauze sponge (USP Type VII Gauze). 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):	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?
48134	Woven gauze pad, non-antimicrobial	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. 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
Device Size Text, specify: 10 cm X 20 cm
Device Size Text, specify: 4 in X 8 in

Device Record Status

Public Device Record Key: b035b73e-5605-420f-9aa6-c781d5ba51f2
Public Version Date: April 18, 2025
Public Version Number: 4
DI Record Publish Date: October 23, 2018