| 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 | 
| 08432984001582 | Organic Cotton Non Applicator tampons distributed in bulk | 
| 08432984001575 | Organic Non Applicator tampons distributed in bulk | 
| 08432984001568 | Organic Non Applicator Tampons distributed in bulk | 
| 08432984001261 | Organic cotton tampons distributed in bulk. | 
| 08432984001254 | Organic cotton cardboard applicator tampons distributed in bulk. | 
| 08432984001247 | Organic cotton tampons distributed in bulk |