Laparoscope

GUDID 04059082003399

SOPRO-COMEG GmbH

Rigid optical laparoscope
Primary Device ID04059082003399
NIH Device Record Keyfe5b8fed-5d8b-4176-8223-c6ebe4a81a82
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaparoscope
Version Model Number162 053 040BC001
Company DUNS507185952
Company NameSOPRO-COMEG GmbH
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104059082003399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082003399]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

On-Brand Devices [Laparoscope]

04059082032313163 312 992
04059082032306163 312 990
04059082032290162 122 771
04059082032283162 112 852
04059082032276162 112 850
04059082032269162 104 503
04059082032252162 104 502
04059082032245162 104 500
04059082032238162 103 253
04059082032221162 103 252
04059082032214162 103 250
04059082032207162 102 760
04059082032191162 102 740
04059082032184162 102 730
04059082032160162 054 503
04059082032153162 054 502
04059082032146162 054 500
04059082032139162 053 153
04059082032122162 053 152
04059082032115162 053 150
04059082032108162 053 043
04059082032092162 053 042
04059082032085162 053 040
04059082003849163 312 992BC001
04059082003832163 312 990BC001
04059082003733162 122 771BC001
04059082003726162 112 852BC001
04059082003719162 112 850BC001
04059082003702162 104 503BC001
04059082003696162 104 502BC001
04059082003689162 104 500BC001
04059082003672162 103 253BC001
04059082003658162 103 252BC001
04059082003634162 103 250BC001
04059082003580162 102 760BC001
04059082003573162 102 740BC001
04059082003566162 102 730BC001
04059082003528162 054 503BC001
04059082003511162 054 502BC001
04059082003504162 054 500BC001
04059082003481162 053 153BC001
04059082003467162 053 152BC001
04059082003443162 053 150BC001
04059082003436162 053 043BC001
04059082003412162 053 042BC001
04059082003399162 053 040BC001

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