FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MEGAPULSE 15+
DI: 04055207053980
·
Model: 487501235
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- MEGAPULSE 15+
- Primary DI
- 04055207053980
- Version / Model
- 487501235
- Catalog Number
- 487501235
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2017-06-28
- Public Version
- 6
- Public Version Date
- 2023-05-29
- Public Version Status
- Update
- Public Device Record Key
- b0066cac-3884-4fd3-b372-92901bca9822
- Distribution End Date
- 2017-10-17
Device Description
LASER FIBER Ø 230µM DISPOSABLE Core Diameter 230µm, PACK=5 PCS, sterile, for single use
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered laser surgical instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36037 | Laser lithotripsy system | An assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi). The assembly transmits the laser energy to the stone(s) which fragment. The debris may be removed forcefully or passed out later by natural means. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207053980 | GS1 | ||||
| Unit of Use | 04055207053997 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 230 | Micrometer |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius