FDA UDI In Commercial Distribution 🇺🇸 United States

LiNA Xcise™, Laparoscopic Morcellator

DI: 05708265015139 · Model: MOR2-1515-6 · LiNA Medical AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
LiNA Xcise™, Laparoscopic Morcellator
Primary DI
05708265015139
Version / Model
MOR2-1515-6
Company Name
LiNA Medical AG
Labeler DUNS
485705870
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-04-02
Public Version
1
Public Version Date
2026-04-10
Public Version Status
New
Public Device Record Key
6bcfe78d-ca63-4203-bd22-c147a49e3e48

Device Description

15 mm 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
HET Laparoscope, Gynecologic (And Accessories)

GMDN Terms

Code Name
64199 Tissue morcellation system handpiece, battery-powered

Identifiers

Type ID
Package 05708265015146
Primary 05708265015139