| Primary Device ID | 08800039006590 | 
| NIH Device Record Key | ae03a95b-0096-4b26-88ec-4be2171a2373 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Biotex | 
| Version Model Number | BT401655D | 
| Company DUNS | 687429456 | 
| Company Name | PURGO BIOLOGICS 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 | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08800039006590 [Primary] | 
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-05-02 | 
| Device Publish Date | 2025-04-24 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  BIOTEX  90976585  not registered Live/Pending | Premier Dental Products Company 2020-09-08 | 
|  BIOTEX  90166159  not registered Live/Pending | Premier Dental Products Company 2020-09-08 | 
|  BIOTEX  88839169  not registered Live/Pending | Sysco Guest Supply, LLC 2020-03-18 | 
|  BIOTEX  88839163  not registered Live/Pending | Sysco Guest Supply, LLC 2020-03-18 | 
|  BIOTEX  85386244  4234971 Dead/Cancelled | Progressive Wound Care Technologies, LLC 2011-08-01 | 
|  BIOTEX  79242050  not registered Live/Pending | KANG, Ho Chang 2018-07-23 | 
|  BIOTEX  77753877  not registered Dead/Abandoned | Crossfield Products Corporation 2009-06-07 | 
|  BIOTEX  76010433  not registered Dead/Abandoned | Societe Anonyme Suprarev 2000-03-27 | 
|  BIOTEX  74510696  1973315 Live/Registered | LEVY, NATALIE 1994-04-11 | 
|  BIOTEX  74301452  not registered Dead/Abandoned | INTERMA Textilproduktions- und Handels GmbH 1992-08-04 | 
|  BIOTEX  74301451  not registered Dead/Abandoned | INTERMA Textilproduktions- und Handels GmbH 1992-08-04 | 
|  BIOTEX  74138062  not registered Dead/Abandoned | KORTMAN INTRADAL B.V. 1991-02-11 |