FDA UDI
In Commercial Distribution
🇺🇸 United States
LiNA Xcise™, Laparoscopic Morcellator
DI: 05708265012527
·
Model: MOR2-1515-6
·
Lina Medical ApS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LiNA Xcise™, Laparoscopic Morcellator
- Primary DI
- 05708265012527
- Version / Model
- MOR2-1515-6
- Catalog Number
- MOR2-1515-6
- Company Name
- Lina Medical ApS
- Labeler DUNS
- 305088619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-02
- Public Version
- 1
- Public Version Date
- 2020-12-10
- Public Version Status
- New
- Public Device Record Key
- 6223b84c-2ca9-47d6-a8d7-9860405981a7
Device Description
15mm battery powered morcellator system with obturator
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64199 | Tissue morcellation system handpiece, battery-powered | A battery-powered, hand-held device 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 (e.g., prostate tissue morcellation during laparoscopy). It consists of a cordless instrument with a high-speed rotating blade in a holder. 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 |
|---|---|---|---|---|---|---|
| Package | 05708265012534 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 05708265012527 | GS1 |
Customer Contacts
- Phone
- +48612222121
- [email protected]