AutoLap Single Procedure Kit Pack- (Ring, 5mm)

GUDID 17290016648260

The Ring procedure kit box contains: Ring unit- 1/box, Clippers set (5mm)- 1/box

M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD

Laparoscope holder Laparoscope holder
Primary Device ID17290016648260
NIH Device Record Key80a74a6d-1be6-4e77-ae12-750349d27249
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoLap Single Procedure Kit Pack- (Ring, 5mm)
Version Model NumberASS06520US
Company DUNS649827193
Company NameM.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290016648260 [Primary]
GS127290016648267 [Package]
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

Devices Manufactured by M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD

17290016648079 - AutoLap ARM Unit Package2019-03-11
17290016648246 - AutoLap Sterile Drape2019-03-11
07290016648027 - AutoLap ARM2019-03-11
07290016648034 - AutoLap Curved ARM2019-03-11
07290016648058 - AutoLap Cart2019-03-11
07290016648072 - AutoLap ARM Unit2019-03-11
07290016648089 - AutoLap Bar2019-03-11
07290016648096 - AutoLap Curved Bar2019-03-11

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