| Primary Device ID | 10821329000543 |
| NIH Device Record Key | 8c43fc86-3585-47b2-99ef-2c09f55c9b7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PTFE Peelable Introducer Kit |
| Version Model Number | 667097-351 |
| Catalog Number | 7097 |
| 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 |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 70 Millimeter |
| Lumen/Inner Diameter | 3.7 Millimeter |
| Total Volume | 12 Milliliter |
| Needle Gauge | 18 Gauge |
| Length | 60 Centimeter |
| Outer Diameter | 3.9 Millimeter |
| Catheter Gauge | 11 French |
| Lumen/Inner Diameter | 0.9 Millimeter |
| Length | 14 Centimeter |
| 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 |