FDA.reportPublic FDA data

n.a.

Primary DI
04048551357286
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
20090001-45
Device description
SCB control NEO Software Upgrade
Published
2017-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ODAendoscopic central control unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODAEndoscopic Central Control UnitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551357286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551357286040485513572864048551357286

GMDN Terms#

Term, Definition table
TermDefinition
Operating room audiovisual data/device management system application softwareAn application software program, routines, and/or algorithms intended to be used in an operating room audiovisual data/device management system to enable the system to function according to its intended purpose. The software typically supports remote control of medical and non-medical devices, data management/documentation, and data communication/transfer within and outside of the operating room (OR) [e.g., teleconferencing, teaching/ telesurgery, networking with hospital systems]; it is not intended for long-term storage of patient demographics. It is typically installed into a dedicated integrated network of computers and peripherals.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315731430
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551411704NAUF101UF1012025-03-27
04048438006368n.a.030647-10030647-102020-01-11
04048438006429n.a.031529-10031529-102020-01-11
04048438006306n.a.031523-10031523-102019-02-23
04048551440148n.a.091010-10091010-102026-10-16
04048551444559n.a.091011-10091011-102026-10-16
04048551423226HD-VIEW11272VH11272VH2020-01-11
04048551423363HD-VIEW11272VHU11272VHU2020-01-11
04048551161005n.a.408001102018-09-04
04048551291030NAV1408100202018-08-23
04048551325971n.a.408000212016-09-23
04048551160992n.a.408000902016-09-23
04048551277577n.a.408120202018-08-21
04048551325988n.a.408000512016-09-23
04048551336854NAV1408200202018-08-23
04048551337707n.a.408200862018-08-17
04048551337820NAV1408200302018-08-23
04048551271087n.a.408001202016-09-23
04048551387344n.a.408201232019-02-23
04048551387368n.a.408201502017-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556813683INTELLIO TabletSmith & Nephew, Inc.ODA2023-05-17
00885556866108INTELLIO TabletSmith & Nephew, Inc.ODA2023-05-17
04953170435201SYSTEMS INTEGRATION ENDOALPHAOLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-21
04953170328985UPGRADE KIT FOR UCES-3(Version4)OLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-17
04953170144929System CableOLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-16
04953170148040Universal display for ENDOALPHAOLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-16
04953170406461UCES-4 Upgrade Pack 2OLYMPUS MEDICAL SYSTEMS CORP.ODA2020-08-06
00885556778777LENS CONNECTED TOWER APPLICATIONSmith & Nephew, Inc.ODA2020-03-22
04048551416778n.a.Karl Storz GmbH & Co. KGODA2020-03-02
04953170391767MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391804EXTENSION UNIT FOR UCES-4OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391842INTERFACE FOR ESU (VIO SERIES)OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391873INTERFACE FOR ESU (FORCE SERIES)OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391903UNIVERSAL INTERFACEOLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391965INTERFACE FOR OLYMPUS LINK DEVICEOLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04048551242575n.a.Karl Storz GmbH & Co. KGODA2018-08-17
04048551392270n.a.Karl Storz GmbH & Co. KGODA2017-10-20
04953170136597REMOTE CABLEOLYMPUS MEDICAL SYSTEMS CORP.ODA2017-10-12
04055207013397NARichard Wolf GmbHODA2017-07-21
04055207013403NARichard Wolf GmbHODA2017-07-21
04055207013410NARichard Wolf GmbHODA2017-07-21
04055207013427NARichard Wolf GmbHODA2017-07-21
04055207013434NARichard Wolf GmbHODA2017-07-21
04055207013441NARichard Wolf GmbHODA2017-07-21
04055207041031NARichard Wolf GmbHODA2017-07-21
04055207057476NARichard Wolf GmbHODA2017-07-21
04055207057506NARichard Wolf GmbHODA2017-07-21
04055207057513NARichard Wolf GmbHODA2017-07-21
04055207057520NARichard Wolf GmbHODA2017-07-21
04055207057537NARichard Wolf GmbHODA2017-07-21