AccessGUDID - DEVICE: ENDURE INDUSTRIES (00840118609654)

GUDID

Device Identifier (DI) Information

Brand Name: ENDURE INDUSTRIES
Version or Model: WGN218
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WGN218
Company Name: ENDURE INDUSTRIES

Primary DI Number: 00840118609654
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066087031 *Terms of Use

Device Description: Non-st. Gauze swab, folded edge (11 thr, 2 * 2", 8ply)

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?
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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 0 and 49 Degrees Celsius
Storage Environment Temperature: between 0 and 49 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cc2c97e7-9298-4a8a-a1fe-9a4f930ced4f
Public Version Date: April 18, 2025
Public Version Number: 2
DI Record Publish Date: October 15, 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
00840118609661	100	00840118609654		In Commercial Distribution	Inner Pack
00840118614061	10000	00840118609654		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1 607-299-4971
Email: support@endureind.com

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