AccessGUDID - DEVICE: Eroxon (00307663074806)

GUDID

Device Identifier (DI) Information

Brand Name: Eroxon
Version or Model: Four Pack
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Haleon US Holdings LLC

Primary DI Number: 00307663074806
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 079944263 *Terms of Use

Device Description: Four single-use tubes of Eroxon gel in one carton.

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):	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?
66929	Penile cooling/warming gel	A gel/jelly-like substance intended to be applied to the head of the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for sexual intercourse. The gel stimulates erection by providing a cooling effect as the volatile components (e.g., alcohol, water) evaporate, followed by a warming effect due to the body’s efferent response (thermoregulation), resulting in increased blood flow to the penis. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QWW	Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN220078	000

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 22758c0a-7a69-4987-9e45-69f4fb4dc778
Public Version Date: October 04, 2024
Public Version Number: 1
DI Record Publish Date: September 26, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00307663075896 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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