N/A 0915612-06

GUDID 04048551446584

Karl Storz GmbH & Co. KG

Flexible video intubation laryngoscope, single-use
Primary Device ID04048551446584
NIH Device Record Key182a063f-0b7f-48cd-b522-880f54053119
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number0915612-06
Catalog Number0915612-06
Company DUNS315731430
Company NameKarl Storz GmbH & Co. KG
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS104048551446584 [Unit of Use]
GS104048551446690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (flexible or rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-22
Device Publish Date2023-08-14

On-Brand Devices [N/A]

040485514465840915612-06
04048551441909C-MAC Videolaryngoskop MAC #3
04048551279540FISCH Titanium Stapes Piston, 0.4 x 7 mm
04048551279502FISCH Titanium Incus Prosthesis, 1.3/2.0mm x 3 mm
04048551279496FISCH Titanium Incus Prosthesis, 1.3/2.0mm x 4 mm
04048551279489FISCH Titanium Incus Prosthesis, 1.3/2.0mm x 5 mm
04048551279472FISCH Titanium Neomalleus Prosthesis, 1.1 x 5 mm
04048551279465FISCH Titanium Stapes Piston, 0.4 x 8.5 mm
04048551279458FISCH Titanium Stapes Piston, 0.4 x 10 mm
04048551279441FISCH Titanium Total Prosthesis with Foot, 0.6 x 10 mm

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