FDA UDI
In Commercial Distribution
🇺🇸 United States
PANOVIEW
DI: 04055207023266
·
Model: 8964401
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PANOVIEW
- Primary DI
- 04055207023266
- Version / Model
- 8964401
- Catalog Number
- 8964.401
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 83a86ad3-4ced-486f-883a-e9ebb695c0c1
Device Description
NEPHROSCOPE 12° 20.8FR WL 224MM rigid, with parallel ocular lens, working channel for instruments up to 10.5Fr, TL 387mm, rod lens system
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
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGA | Kit, nephroscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15290 | Rigid optical nephroscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the kidney. It is inserted percutaneously into the renal pelvis during nephroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the internal structures of the kidney and may be used in the removal of renal calculi. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207023266 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 224 | Millimeter | |
| Angle | 12 | degree | |
| Outer Diameter | 6.93333333333 | Millimeter |