FDA UDI
Not in Commercial Distribution
🇺🇸 United States
E-LINE
DI: 04055207020111
·
Model: 8704523
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- E-LINE
- Primary DI
- 04055207020111
- Version / Model
- 8704523
- Catalog Number
- 8704.523
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 5a078b1f-c7d9-4169-a119-99d7d2517d21
- Distribution End Date
- 2018-08-01
Device Description
URETERORENOSCOPE 12° 8.5/11.5FR WL 315MM semi-rigid, with lateral ocular lens, working channel 1x6 (2x4)Fr, atraumatic distal tip, TL 484mm, fiber image carrier
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
- ["Ethylene Oxide", "Hydrogen Peroxide", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGB | Ureteroscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37112 | Rigid optical ureterorenoscope | An endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. It is inserted through the external urethral orifice during a urological procedure whereby anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used for the crushing or removal of stones and evaluation of pyelitis or renal failure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207020111 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 315 | Millimeter | |
| Angle | 12 | degree |