AccessGUDID - DEVICE: P.S. (00860001852400)

GUDID

Device Identifier (DI) Information

Brand Name: P.S.
Version or Model: Exceptionally Thin Latex Condoms
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ISSAWRAP INC

Primary DI Number: 00860001852400
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 029021726 *Terms of Use

Device Description: This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180 mm, nominal width 52 mm, and nominal thickness 0.045mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and IS0 407. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections.

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):	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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 98ce29f0-aba7-4a50-835d-503333322b9d
Public Version Date: June 11, 2019
Public Version Number: 1
DI Record Publish Date: June 03, 2019