VersaCut+ Tissue Morcellator with Regular Handpiece

GUDID 07290109140643

LUMENIS LTD.

Tissue morcellation system handpiece, line-powered
Primary Device ID07290109140643
NIH Device Record Keyd3ba885f-c583-48bf-b80e-b7a16f50fc16
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersaCut+ Tissue Morcellator with Regular Handpiece
Version Model NumberVersaCut+ Tissue Morcellator with Regular Handpiec
Company DUNS600166524
Company NameLUMENIS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone408-764-3000
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109140643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2016-08-23

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