FDA UDI
In Commercial Distribution
🇺🇸 United States
Navigator 3 Wireless Probe Battery Pack
DI: 04260152884514
·
Model: PU-WP-01
·
crystal-photonics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Navigator 3 Wireless Probe Battery Pack
- Primary DI
- 04260152884514
- Version / Model
- PU-WP-01
- Catalog Number
- 120924
- Company Name
- crystal-photonics GmbH
- Labeler DUNS
- 506883144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-19
- Public Version
- 1
- Public Version Date
- 2024-03-27
- Public Version Status
- New
- Public Device Record Key
- 03b9416b-e7d8-4562-a63d-ddaa5cca3d46
Device Description
gamma probe system, battery pack for wireless probes
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | Radiology | 892.1320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40646 | Hand-held-detector nuclear medicine system | An assembly of diagnostic devices comprising a hand-held, non-imaging system designed primarily to detect, record, quantify and analyse various radioactive emissions (gamma, alpha, beta) of injected or ingested radiopharmaceuticals, radiation emitting devices, or other materials. It is frequently used in the monitoring and detection of deep vein thrombosis (DVT), in surgical procedures requiring radionuclide localization and in some radiolabeled monoclonal antibody applications. It often has special software or accessory features that distinguish them from similar devices used for radiation protection purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260152884514 | GS1 |