RadialSeal™ Introducer Kit, SS Wire
GUDID 20821329000458
Greatbatch Ltd
Vascular catheter introduction set, nonimplantable| Primary Device ID | 20821329000458 |
| NIH Device Record Key | d7686454-c9ba-4997-81f2-ecb6bb8c82a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RadialSeal™ Introducer Kit, SS Wire |
| Version Model Number | SPC-000653-008 |
| 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 | 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 |
Device Dimensions
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 38 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.9 Millimeter |
| Catheter Gauge | 5 French |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Length | 16 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821329000454 [Primary] |
| GS1 | 20821329000458 [Package] Contains: 00821329000454 Package: BOX [5 Units] In Commercial Distribution |
FDA Product Code
| DYB | Introducer, Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-23 |
| Device Publish Date | 2018-09-24 |
On-Brand Devices [RadialSeal™ Introducer Kit, SS Wire]
| 20821329400784 | SPC-000653-006 |
| 20821329400777 | SPC-000653-005 |
| 20821329400760 | SPC-000653-004 |
| 20821329400753 | SPC-000653-003 |
| 20821329400746 | SPC-000653-002 |
| 20821329400739 | SPC-000653-001 |
| 20821329000458 | SPC-000653-008 |
| 20821329000441 | SPC-000653-009 |
| 20821329000434 | SPC-000653-007 |
Trademark Results [RadialSeal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RADIALSEAL 87265454 5644092 Live/Registered |
Integer Holdings Corporation 2016-12-12 |
 RADIALSEAL 74425905 1887753 Dead/Cancelled |
Donaldson Company, Inc. 1993-08-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.