Primary Device ID | 08859798105020 |
NIH Device Record Key | 9b9b5b5f-0383-4e12-b994-3f3deac54b9b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bikini |
Version Model Number | 08859798105020 |
Company DUNS | 672044515 |
Company Name | SURETEX LIMITED - BRANCH |
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 | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08859798105020 [Primary] |
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 | 2025-08-07 |
Device Publish Date | 2025-07-30 |
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18859798107380 - LIFESTYLES | 2025-09-12 LifeStyles Ultra Sensitive Latex Condom 1008 RP |