TELE PACK

GUDID 04048551006689

TELE PACK X

Karl Storz GmbH & Co. KG

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit
Primary Device ID04048551006689
NIH Device Record Keyb20ee1e1-c402-4888-8965-1dfae76cf020
Commercial Distribution StatusIn Commercial Distribution
Brand NameTELE PACK
Version Model Number20045020
Company DUNS315731430
Company NameKarl Storz GmbH & Co. KG
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104048551006689 [Primary]
GS104048551006689 [Primary]
GS104048551006689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCTLight source, endoscope, xenon arc
GCTLight source, endoscope, xenon arc
GCTLight source, endoscope, xenon arc

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-19
Device Publish Date2016-09-23

On-Brand Devices [TELE PACK]

04048551425701TELE PACK +
04048551322925TELE PACK X LED
04048551006689TELE PACK X

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