| Primary Device ID | 00855019008093 |
| NIH Device Record Key | 09f5d739-600a-4fe0-88ad-4decd304fac8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | re.t.a |
| Version Model Number | THRT0101 |
| Company DUNS | 116162108 |
| Company Name | R.K. MANUFACTURING CORPORATION OF CONNECTICUT |
| 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 | 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | (917) 819-8171 |
| hello@shethinx.com | |
| Phone | (917) 819-8171 |
| hello@shethinx.com | |
| Phone | (917) 819-8171 |
| hello@shethinx.com | |
| Phone | (917) 819-8171 |
| hello@shethinx.com | |
| Phone | (917) 819-8171 |
| hello@shethinx.com | |
| Phone | (917) 819-8171 |
| hello@shethinx.com | |
| Phone | (917) 819-8171 |
| hello@shethinx.com | |
| Phone | (917) 819-8171 |
| hello@shethinx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855019008093 [Primary] |
| HEB | Tampon, Menstrual, Unscented |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-14 |
| Device Publish Date | 2019-01-14 |
| 00855019008093 - re.t.a | 2019-02-14Reusable Tampon Applicator |
| 00855019008093 - re.t.a | 2019-02-14 Reusable Tampon Applicator |
| 00855019008000 - epic edge | 2019-02-07 10/0 BL Mono Nylon, 10 cm length, 1/2 cir Spatula Ndl, Single Arm (single device) |
| 00855019008017 - epic edge | 2019-02-07 10/0 BL Mono Nylon, 10 cm length, 3/8 cir Spatula Ndl, Single Arm (single device) |
| 00855019008024 - epic edge | 2019-02-07 10/0 BL Mono Nylon, 30 cm length, 1/2 cir Spatula Ndl, Double Arm (single device) |
| 00855019008031 - epic edge | 2019-02-07 10/0 BL Mono Nylon, 30 cm length, 3/8 cir Spatula Ndl, Double Arm (single device) |