| Primary Device ID | D7950000131 |
| NIH Device Record Key | 2131347b-76d7-478d-b4a4-ae2e4ff619fd |
| Commercial Distribution Discontinuation | 2019-03-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | GLUSTITCH TWIST |
| Version Model Number | GLTWI05 |
| Company DUNS | 201637158 |
| Company Name | Glustich Inc |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 1-877-940-2262 |
| info@glustitch.com | |
| Phone | 1-877-940-2262 |
| info@glustitch.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7950000130 [Primary] |
| HIBCC | D7950000131 [Package] Contains: D7950000130 Package: BOX [6 Units] Discontinued: 2019-03-01 Not in Commercial Distribution |
| HIBCC | D7950000132 [Package] Contains: D7950000130 Package: BOX [12 Units] Discontinued: 2019-03-01 Not in Commercial Distribution |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-01 |
| Device Publish Date | 2017-02-13 |
| D795G000151 | GLTWI05C |
| D7950000131 | GLTWI05 |