AccessGUDID - DEVICE: SKORE Thin Condoms with Flavors (08906007135511)

GUDID

Device Identifier (DI) Information

Brand Name: SKORE Thin Condoms with Flavors
Version or Model: SKORE SKINTHIN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TTK HEALTHCARE LIMITED

Primary DI Number: 08906007135511
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 675476406 *Terms of Use

Device Description: The SKORE Thin Condoms with flavors - SKORE SKINTHIN condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, silicone oil with Zeus odor masker male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE SKINTHIN natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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 [?]
K230049	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: a3f8537a-5c90-4bc3-895c-e181bb935b9e
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
08906007135528	3	08906007135511	In Commercial Distribution	Wallet
08906007135535	240	08906007135528	In Commercial Distribution	Carton
08906007135542	2160	08906007135535	In Commercial Distribution	Case