AccessGUDID - DEVICE: Dong! (00085004341199)

GUDID

Device Identifier (DI) Information

Brand Name: Dong!
Version or Model: Dong! Latex Condoms
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11406
Company Name: MAYER LABORATORIES, INC.

Primary DI Number: 00085004341199
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 175425982 *Terms of Use

Device Description: Latex Condom 3-ct

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):	Yes
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?
45138	Basic male condom, Hevea-latex	A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIS	CONDOM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 40 and 90 Degrees Fahrenheit
Special Storage Condition, Specify: NO DIRECT SUNLIGHT OR HEAT

Clinically Relevant Size

[?]

Size Type Text
Length: 160 Millimeter
Width: 53 Millimeter

Device Record Status

Public Device Record Key: 6cf17935-024f-4a7e-aab6-77a16fc28410
Public Version Date: November 13, 2023
Public Version Number: 1
DI Record Publish Date: November 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
20085004341193	6	00085004341199		In Commercial Distribution	FOLDED CARTON
10085004341196	8	20085004341193		In Commercial Distribution	MASTER CARTON

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 30085004341190 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

[?]

Phone: +1(510)229-5300 ext: 5305
Email: davidm@mayerlabs.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES