FAMA Male Latex Condoms

GUDID 16936296700113

Condom

Shanghai Personage Hygiene Products Co.,Ltd.

Basic male condom, Hevea-latex

• Primary Device ID: 16936296700113
• NIH Device Record Key: 934a0832-5e9a-4485-87a5-dfb74f01a481
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAMA Male Latex Condoms
• Version Model Number: 53mm,Condom(Ribbed)
• Company DUNS: 529430956
• Company Name: Shanghai Personage Hygiene Products Co.,Ltd.
• Device Count: 1
• 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: false
• 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: true

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936296700116 [Primary]
GS1	16936296700113 [Package]; Contains: 06936296700116; Package: Carton [10 Units]; Discontinued: 2024-07-26; Not in Commercial Distribution
GS1	26936296700110 [Package]; Package: Case [112 Units]; Discontinued: 2024-07-26; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220576

FDA Product Code

• HIS: Condom

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-05
• Device Publish Date: 2024-07-26

On-Brand Devices [FAMA Male Latex Condoms]

• 16936296700076: Condom
• 16936296700045: Condom
• 16936296700038: Condom
• 16936296700021: Condom
• 16936296700014: Condom
• 16936296700113: Condom
• 16936296700106: Condom
• 16936296700090: Condom
• 16936296700083: Condom
• 16936296700069: Condom
• 16936296700052: Condom