ONE Flex Condoms

GUDID 80726893115138

ONE Flex USA 10-Packs, Case of 72 (24 bundles of 3)

GLOBAL PROTECTION CORP.

Basic male condom, Hevea-latex

• Primary Device ID: 80726893115138
• NIH Device Record Key: 463cec07-c751-422c-b70a-01329d9b4a1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE Flex Condoms
• Version Model Number: 1131010C
• Company DUNS: 364614362
• Company Name: GLOBAL PROTECTION CORP.
• Device Count: 10
• 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 at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	20726893115136 [Primary]
GS1	80726893115138 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203536

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: 2023-08-25
• Device Publish Date: 2023-08-17

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