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 ID80726893115138
NIH Device Record Key463cec07-c751-422c-b70a-01329d9b4a1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE Flex Condoms
Version Model Number1131010C
Company DUNS364614362
Company NameGLOBAL PROTECTION CORP.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS120726893115136 [Primary]
GS180726893115138 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-25
Device Publish Date2023-08-17

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