RadialSeal™ Introducer Kit, Poly Wire
GUDID 20821329000465
Greatbatch Ltd
Vascular catheter introduction set, nonimplantable| Primary Device ID | 20821329000465 |
| NIH Device Record Key | a072911b-9dc8-4e42-a995-819003803bc2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RadialSeal™ Introducer Kit, Poly Wire |
| Version Model Number | SPC-000654-007 |
| 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 | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
| Device Size Text, specify | 0 |
| Length | 25 Millimeter |
| Lumen/Inner Diameter | 0.55 Millimeter |
| Length | 80 Centimeter |
| Outer Diameter | 0.54 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Outer Diameter | 1.5 Millimeter |
| Catheter Gauge | 4 French |
| Lumen/Inner Diameter | 1.3 Millimeter |
| Length | 16 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821329000461 [Primary] |
| GS1 | 20821329000465 [Package] Contains: 00821329000461 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, Poly Wire]
| 20821329400845 | SPC-000654-006 |
| 00821329400834 | SPC-000654-005 |
| 20821329400821 | SPC-000654-004 |
| 20821329400814 | SPC-000654-003 |
| 20821329400807 | SPC-000654-002 |
| 20821329400791 | SPC-000654-001 |
| 20821329000489 | SPC-000654-009 |
| 20821329000472 | SPC-000654-008 |
| 20821329000465 | SPC-000654-007 |
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 |
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