FDA UDI
In Commercial Distribution
🇺🇸 United States
VersaCut™
DI: 07290109146850
·
Model: VersaCut™
·
LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VersaCut™
- Primary DI
- 07290109146850
- Version / Model
- VersaCut™
- Catalog Number
- 0636-470-01
- Company Name
- LUMENIS LTD.
- Labeler DUNS
- 600166524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-04
- Public Version
- 1
- Public Version Date
- 2022-09-12
- Public Version Status
- New
- Public Device Record Key
- dd80a1b0-9e45-4137-8385-8228785568a5
Device Description
VersaCut Tissue Morcellator Control Unit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46730 | Tissue morcellation system control unit | A mains electricity (AC-powered) component of a tissue morcellation system used to power and regulate the system's handpiece blade via cable connection; some designs may also provide suction intended for removal of resected tissue. This device will typically have hand and/or foot controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109146850 | GS1 |