FDA UDI
In Commercial Distribution
🇺🇸 United States
VersaCut+ Tissue Morcellator with Regular Handpiece
DI: 07290109140643
·
Model: VersaCut+ Tissue Morcellator with Regular Handpiece
·
LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VersaCut+ Tissue Morcellator with Regular Handpiece
- Primary DI
- 07290109140643
- Version / Model
- VersaCut+ Tissue Morcellator with Regular Handpiece
- Company Name
- LUMENIS LTD.
- Labeler DUNS
- 600166524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-23
- Public Version
- 5
- Public Version Date
- 2025-02-26
- Public Version Status
- Update
- Public Device Record Key
- d3ba885f-c583-48bf-b80e-b7a16f50fc16
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 |
|---|---|---|---|---|
| 46732 | Tissue morcellation system handpiece, line-powered | A hand-held component of a tissue morcellation system intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery. It consists of a high-speed rotating blade in a holder and is connected to a line-powered control unit for the transfer of electrical energy or rotational power (via an electrical or remote drive cable); a handpiece obturator, and a disposable remote drive cable may be included. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109140643 | GS1 |
Customer Contacts
- Phone
- 408-764-3000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133272 | 000 |