Primary Device ID | 10067981160489 |
NIH Device Record Key | 176f3a85-449d-426e-8083-12735dc310d4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DUREX Extra Sensitive Smooth Condom |
Version Model Number | Condom |
Company DUNS | 081049410 |
Company Name | RB Health (us) LLC |
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 | true |
Phone | +1(800)756-5488 |
xxx@xxx.xxx |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00067981160482 [Primary] |
GS1 | 10067981160489 [Package] Contains: 00067981160482 Package: Carton [3 Units] In Commercial Distribution |
GS1 | 20067981160486 [Package] Package: Case [6 Units] In Commercial Distribution |
GS1 | 40067981160480 [Unit of Use] |
HIS | CONDOM |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-04-17 |
Device Publish Date | 2020-04-09 |
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