ONE Classic Select MSM Collection

GUDID 80726893111789

1,000 Lubricated Male Latex Condoms

GLOBAL PROTECTION CORP.

Basic male condom, Hevea-latex

• Primary Device ID: 80726893111789
• NIH Device Record Key: 5397350b-faa6-4826-9ccb-5848437a509a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE Classic Select MSM Collection
• Version Model Number: 11000CY
• Company DUNS: 364614362
• Company Name: GLOBAL PROTECTION CORP.
• Device Count: 1000
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20726893111787 [Primary]
GS1	80726893111789 [Unit of Use]

FDA Product Code

• QRZ: External Condom For Anal Intercourse Or Vaginal Intercourse

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-04-21
• Device Publish Date: 2020-06-02

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