| Primary Device ID | 10821329400633 |
| NIH Device Record Key | c9d13e20-b30e-444d-b01b-7d34f74d1e4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PTFE Peelable Introducer Kit |
| Version Model Number | 667133-304 |
| Catalog Number | 7133 |
| Company DUNS | 968623467 |
| Company Name | Greatbatch 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Lumen/Inner Diameter | 4.1 Millimeter |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821329400636 [Primary] |
| GS1 | 10821329400633 [Package] Contains: 00821329400636 Package: box [1 Units] In Commercial Distribution |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |