| Primary Device ID | 00733132612161 |
| NIH Device Record Key | c10e67c9-bfdd-49bd-a453-e4b15328e40f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GORE DrySeal Sheath |
| Version Model Number | SDV2228 |
| Catalog Number | SDV2228 |
| 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 | 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 |
| Length | 28 Centimeter |
| Length | 28 Centimeter |
| Length | 28 Centimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Outer Diameter | 8 Millimeter |
| Length | 28 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132612161 [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 | 2017-02-13 |
| 00733132620005 | DRYSEAL LUBRICIOUS 26F Hydrophilic Coating |
| 00733132619993 | DRYSEAL LUBRICIOUS 24F Hydrophilic Coating |
| 00733132619986 | DRYSEAL LUBRICIOUS 22F Hydrophilic Coating |
| 00733132619979 | DRYSEAL LUBRICIOUS 20F Hydrophilic Coating |
| 00733132619962 | DRYSEAL LUBRICIOUS 18F Hydrophilic Coating |
| 00733132619955 | DRYSEAL LUBRICIOUS 16F Hydrophilic Coating |
| 00733132619948 | DRYSEAL LUBRICIOUS 14F Hydrophilic Coating |
| 00733132619931 | DRYSEAL LUBRICIOUS 12F |
| 00733132612185 | SDV INTRODUCER SHEATH 26F |
| 00733132612178 | SDV INTRODUCER SHEATH 24F |
| 00733132612161 | SDV INTRODUCER SHEATH 22F |
| 00733132612154 | SDV INTRODUCER SHEATH 20F |
| H373SDV18283 | SDV INTRODUCER SHEATH 18F |
| 00733132612123 | SDV INTRODUCER SHEATH 14F |
| 00733132612116 | SDV INTRODUCER SHEATH 12F |