AccessGUDID - DEVICE: Gazetex® (00809958000243)

GUDID

Device Identifier (DI) Information

Brand Name: Gazetex®
Version or Model: 4500L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DUP4500L
Company Name: Derma Sciences Canada Inc

Primary DI Number: 00809958000243
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 400
Labeler D-U-N-S® Number*: 200564891 *Terms of Use

Device Description: Gazetex 1.5 in X 2 in diameter "krinkle" type prep sponge. Large with twisted knot. Bulk packed 400/case

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?
44971	General-purpose surgical sponge	A non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. 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: 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: 1.5 in X 2 in

Device Record Status

Public Device Record Key: 829b4df0-957e-431d-b70e-a578d4a73970
Public Version Date: June 25, 2024
Public Version Number: 3
DI Record Publish Date: October 23, 2018