AccessGUDID - DEVICE: Primeros (19556807313891)

GUDID

Device Identifier (DI) Information

Brand Name: Primeros
Version or Model: The King 3's
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QA-224
Company Name: RICHTER RUBBER TECHNOLOGY SDN. BHD.

Primary DI Number: 19556807313891
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 652647942 *Terms of Use

Device Description: Natural latex male condom. Transparent, flared shaped, nominal width 57 mm, smooth with reservoir. Lubricated with silicone oil. 100% electronically tested.”

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 [?]
K070511	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
Special Storage Condition, Specify: Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9572d045-706f-44ff-b1bf-ea99ab5eb5a9
Public Version Date: May 13, 2024
Public Version Number: 1
DI Record Publish Date: May 03, 2024