| Primary Device ID | 05037881153186 |
| NIH Device Record Key | 5a9979db-e1cf-45be-8230-c5a05093ff5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SealPTFE™ |
| Version Model Number | T6008PS |
| Catalog Number | T6008PS |
| Company DUNS | 229053087 |
| Company Name | VASCUTEK LTD |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 60 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Special Storage Condition, Specify | Between 0 and 0 *Store in clean, dry area at room temperature. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05037881153186 [Primary] |
| DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-03-24 |
| Device Publish Date | 2015-10-19 |
| 05037881999173 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Thin Wall Straight with Central Support |
| 05037881153292 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153285 | SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St |
| 05037881153278 | SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St |
| 05037881153261 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153247 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153230 | SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St |
| 05037881153223 | SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St |
| 05037881153216 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153193 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153186 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153179 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153162 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153148 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153131 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153124 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153117 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153094 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153087 | SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St |
| 05037881153070 | SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St |
| 05037881153063 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153056 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153032 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153025 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881153018 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881152981 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881152974 | SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall St |
| 05037881152967 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881152943 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881152936 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881152929 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORC |
| 05037881152899 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152882 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152875 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152868 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152844 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152837 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152820 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152813 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152806 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152790 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152783 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152776 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152769 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152752 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152745 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152738 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152721 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152714 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |
| 05037881152691 | SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Standard Wall Straight WrappedFULLY REINFORCED |