| Primary Device ID | 10821329000505 | 
| NIH Device Record Key | ea6065bb-2455-40ff-afbd-9e0e83fd704a | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | PTFE Peelable Introducer Kit | 
| Version Model Number | 667131-351 | 
| Catalog Number | 7131 | 
| 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 | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 Centimeter | 
| Length | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 | 25 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 |