FDA UDI
In Commercial Distribution
🇺🇸 United States
Navilyst Medical
DI: H965459000
·
Model: 45-900
·
Angiodynamics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Navilyst Medical
- Primary DI
- H965459000
- Version / Model
- 45-900
- Company Name
- Angiodynamics, Inc.
- Labeler DUNS
- 079252781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-21
- Public Version
- 1
- Public Version Date
- 2024-10-29
- Public Version Status
- New
- Public Device Record Key
- 1091439e-5a6f-4e32-a110-846388334dfd
Device Description
MiniStick II Microintroducer Kit 4F, Tearaway Sheath/Dilator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OFL | Percutaneous Sheath Introducer Kit | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of 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 | H965459001 | HIBCC | Box | 5 | In Commercial Distribution | |
| Primary | H965459000 | HIBCC |
Customer Contacts
- Phone
- +1(800)772-6446
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 21 | Gauge | |
| Guidewire Length | 60 | Centimeter | |
| Guidewire Diameter | 0.018 | Inch | |
| Catheter Gauge | 4 | French | |
| Catheter Length | 7 | Centimeter |