AccessGUDID - DEVICE: kamasutra 12s Plain condom (08909014000438)

GUDID

Device Identifier (DI) Information

Brand Name: kamasutra 12s Plain condom
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: R & A Logistics Inc

Primary DI Number: 08909014000438
Issuing Agency: GS1
Commercial Distribution End Date: July 18, 2028
Device Count: 1
Labeler D-U-N-S® Number*: 118949511 *Terms of Use

Device Description: Pink coloured plain 53mm lubricated male latex condom , each pack contains 12 plain lubricated condom - manfactured by Raymond Lifestyle Limited, Plot No G 35 & 36,MIDC,Waluj, Aurangabad, State Maharashtra, India, Pincode-431136

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
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 [?]
K931077	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: 958bb5e3-72e6-404e-b3ec-e8513c6dc277
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 20, 2024