FDA.reportPublic FDA data

n.a.

Primary DI
04048551049297
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
10905M
Device description
Metal rack for resting telescopes
Published
2018-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551049297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551049297040485510492974048551049297

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video imaging systemAn assembly of mains electricity (AC-powered) devices designed to obtain, transmit, and display video images during an endoscopic procedure. It typically consists of one or more video endoscopes, an endoscopic camera, camera control unit, light source with light cables, video recorder, imaging units with perhaps a colour compensation device, a distention unit, and a visual display unit (VDU), all of which is typically placed/mounted onto a trolley (cart) that can be moved to different examination/treatment rooms.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376766133InvictusALPHATEC SPINE, INC.FSM2026-07-30
ESAM1380200003041STOMA®Storz am Mark GmbHFSM2026-07-30
ESAM1380210003041STOMA®Storz am Mark GmbHFSM2026-07-30
ESAM1387030003041STOMA®Storz am Mark GmbHFSM2026-07-30
03700569678968Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-28
10889950157623Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-07-28
00190376768748Segmental Plating SystemALPHATEC SPINE, INC.FSM2026-07-27
00810017915118Saber-C Instrument CaseELEVATION SPINE, INC.FSM2026-07-27
03700569674304Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674311Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674373Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674380Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674397Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674403Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674410Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674427Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674441Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674458Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674465Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680145Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680152Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680169Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680176Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
00190776422011MillenniumAvalign Technologies, Inc.FSM2026-07-24
00840536823717VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
00840536823724VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
07640221370846SCALASpineArt SAFSM2026-07-24
07640221370853SCALASpineArt SAFSM2026-07-24
07640221370860SCALASpineArt SAFSM2026-07-24
00190776421991MillenniumAvalign Technologies, Inc.FSM2026-07-23