| Primary Device ID | 00733132628117 |
| NIH Device Record Key | 3c1e868a-dfa5-4564-9ec4-630c23e14cfc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GORE DRYSEAL FLEX Introducer Sheath |
| Version Model Number | DSF1245 |
| Catalog Number | DSF1245 |
| Company DUNS | 967358115 |
| Company Name | W. L. Gore & Associates, 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Outer Diameter | 4.7 Millimeter |
| Outer Diameter | 4.7 Millimeter |
| Outer Diameter | 4.7 Millimeter |
| Outer Diameter | 4.7 Millimeter |
| Outer Diameter | 4.7 Millimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Length | 55.1 Centimeter |
| Outer Diameter | 4.7 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132628117 [Primary] |
| DYB | INTRODUCER, CATHETER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-28 |
| Device Publish Date | 2016-05-23 |
| 00733132630950 | DSF2433 |
| 00733132630103 | DSF2633 |
| 00733132630073 | DSF2233 |
| 00733132630066 | DSF2033 |
| 00733132630042 | DSF1833 |
| 00733132630028 | DSF1633 |
| 00733132630011 | DSF1533 |
| 00733132630004 | DSF1433 |
| 00733132629961 | DSF1233 |
| 00733132628421 | DSF2665 |
| 00733132628407 | DSF2465 |
| 00733132628384 | DSF2265 |
| 00733132628360 | DSF2065 |
| 00733132628117 | DSF1245 |
| 00733132629978 | DSF1033 |
| 00733132628261 | DSF1065 |
| 00733132628094 | DSF1045 |
| 00733132628346 | DSF1865 |
| 00733132628322 | DSF1665 |
| 00733132628308 | DSF1465 |
| 00733132628285 | DSF1265 |
| 00733132629985 | GORE DRYSEAL FLEX Introducer Sheath 33cm 11Fr Hydrophilic Coating |