AccessGUDID - DEVICE: Nuvasorb (4"x4") (00699923342016)

GUDID

Device Identifier (DI) Information

Brand Name: Nuvasorb (4"x4")
Version or Model: 3342
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3342
Company Name: Cpn Biosciences, LLC

Primary DI Number: 00699923342016
Issuing Agency: GS1
Commercial Distribution End Date: January 10, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079896008 *Terms of Use

Device Description: Surgical sponge, 4"x4"

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):	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
No Device Sizes

Device Record Status

Public Device Record Key: 9ab64cb0-3f48-47dc-9b26-c3fb9cd8e04c
Public Version Date: April 18, 2025
Public Version Number: 3
DI Record Publish Date: October 03, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00699923342252	25	00699923342016	2024-01-10	Not in Commercial Distribution	Box of 25 pouches
00699923342504	24	00699923342252	2024-01-10	Not in Commercial Distribution	Case of 24 boxes