P.S.

GUDID 00860001852400

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.

ISSAWRAP INC

Basic male condom, Hevea-latex

• Primary Device ID: 00860001852400
• NIH Device Record Key: 98ce29f0-aba7-4a50-835d-503333322b9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.S.
• Version Model Number: Exceptionally Thin Latex Condoms
• Company DUNS: 029021726
• Company Name: ISSAWRAP INC
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 909-261-9527
• Email: rajaagnani@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001852400 [Primary]
GS1	00860001852417 [Unit of Use]

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-11
• Device Publish Date: 2019-06-03