FDA UDI
In Commercial Distribution
🇺🇸 United States
RadialSeal™ Introducer Kit, Poly Wire
DI: 00821329000461
·
Model: SPC-000654-007
·
Greatbatch Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- RadialSeal™ Introducer Kit, Poly Wire
- Primary DI
- 00821329000461
- Version / Model
- SPC-000654-007
- Company Name
- Greatbatch Ltd
- Labeler DUNS
- 968623467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 3
- Public Version Date
- 2019-08-23
- Public Version Status
- Update
- Public Device Record Key
- a072911b-9dc8-4e42-a995-819003803bc2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20821329000465 | GS1 | box | 5 | In Commercial Distribution | |
| Primary | 00821329000461 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | NeedleOuter Diameter: 0.9 mm (21 Ga.) | ||
| 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 |