| Primary Device ID | 00821329001604 |
| NIH Device Record Key | 6c2fc063-febc-4458-b5de-a588c75df821 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PTFE Peelable Introducer Kit |
| Version Model Number | 667093-402 |
| 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 |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Device Size Text, specify | 0 |
| Length | 60 Centimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 1.4 Millimeter |
| Length | 14 Centimeter |
| Lumen/Inner Diameter | 3.1 Millimeter |
| Outer Diameter | 3.2 Millimeter |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Catheter Gauge | 9 French |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |