Primary Device ID | 08432984001650 |
NIH Device Record Key | 0b6b9207-4830-4c11-9a48-3bee9cd67164 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | COTTON HIGH TECH SL |
Version Model Number | Menstrual cup Pantone 2425 Size S |
Company DUNS | 476370908 |
Company Name | COTTON HIGH TECH SL |
Device Count | 350 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08432984001650 [Primary] |
GS1 | 08432984001667 [Unit of Use] |
HHE | Cup, Menstrual |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-07-07 |
Device Publish Date | 2018-09-26 |
08432984001650 | Menstrual Cups Pantone 2425 Size S distributed in Bulk |
08432984001346 | Menstrual Cups Pantone 2425 Size L distributed in bulk |
08432984001339 | Menstrual Cups Pantone 2425 Size M distributed in Bulk |
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08432984001247 | Organic cotton tampons distributed in bulk |