FDA UDI
Not in Commercial Distribution
🇺🇸 United States
E-LINE
DI: 04055207010976
·
Model: 865490
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- E-LINE
- Primary DI
- 04055207010976
- Version / Model
- 865490
- Catalog Number
- 8654.90
- 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
- 6
- Public Version Date
- 2024-11-21
- Public Version Status
- Update
- Public Device Record Key
- 0f8cb4b6-ed1b-4057-a3c0-b5d614e0ff4d
- Distribution End Date
- 2018-06-30
Device Description
WORKING ELEMENT FOR PUNCH-LITHO 24-28FR closed, SL 242mm, round, distal end straight, compatible with sheaths from 24-28Fr, continuous irrigation sheaths from 26Fr, and telescopes Ø 4mm, 0°-30°, reusable
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
- No
- Has Lot/Batch Number
- Yes
- 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, Hydrogen Peroxide, Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FBO | CYSTOURETHROSCOPE | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35808 | Stone/foreign-body extraction set | A collection of surgical instruments intended to remove calculi, debris, and/or to retrieve fragments of catheter tubing, wire guides, pull wires, plastic stents and other foreign bodies during urological and/or gastroenterological interventions. It typically consists of a retrieval basket and/or grasping forceps, an introducing sheath or sleeve, and possibly a guidewire; the exact design of the set will vary depending on the surgical method. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207010976 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]