FDA.reportPublic FDA data

INTEGRATION BROKER

Primary DI
03596010589637
Brand
INTEGRATION BROKER
Company
Smith & Nephew, Inc.
Model
72201079
Catalog number
72201079
Device description
SOFTWARE INTEGRATION BROKER HL7
Published
2016-04-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFGDEVICE, COMMUNICATIONS, IMAGES, OPHTHALMIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFGDevice, Communications, Images, OphthalmicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010589637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010589637035960105896373596010589637

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation system application softwareAn individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical navigation system used in computer assisted surgery (CAS) so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
20885556628908NavioPFSDV0016PFSDV00162016-09-21
00885556820964General InstrumentsMA3511NDMA3511ND2023-10-27
00885556822722Capture High Torque Screw SystemMAT-000-02MAT-000-022022-12-21
00885556822937Total Foot System 23210103210102022-12-21
00885556822944Total Foot System 23210123210122022-12-21
00885556828090XT Revision Ankle Replacement SystemMJV551TMJV551T2022-12-21
00885556832431Salto Talaris Total Ankle ProsthesisMJU012TMJU012T2022-12-21
00885556837825Total Foot System 23820003820002022-12-22
00885556840375Total Wrist Fusion System3035113035112022-12-21
00885556841525XT Revision Ankle Replacement SystemMJU944TMJU944T2022-12-21
00885556855003Freedom Wrist Arthroplasty System3480593480592022-12-22
00885556858301PyroCarbon PIP Total Joint SystemOSG-200-00OSG-200-002022-12-22
00885556858325PyroCarbon PIP Total Joint SystemOSG-200-10PVOSG-200-10PV2022-12-22
00885556858349PyroCarbon PIP Total Joint SystemOSG-200-20PVOSG-200-20PV2022-12-22
00885556858363PyroCarbon PIP Total Joint SystemOSG-200-30PVOSG-200-30PV2022-12-22
00885556858387PyroCarbon PIP Total Joint SystemOSG-200-40PVOSG-200-40PV2022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00627987702149Optina FotysOptina Diagnostiques, IncNFG2025-08-29
04260284390013Navilas® Laser System 577sOD-OS GmbHNFG2023-11-21
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.NFG2023-06-12
08720892096401Cassini Guidance SystemCassini Technologies B.V.NFG2023-05-08
04549292182729CANON INC.CANON INC.NFG2020-10-16
00380659982682VERION™Alcon Laboratories, Inc.NFG2020-08-31
00380659982699VERION™Alcon Laboratories, Inc.NFG2020-08-31
00380659982705VERION™Alcon Laboratories, Inc.NFG2020-08-31
00380659982811VERION™Alcon Laboratories, Inc.NFG2020-08-31
04049471100020FORUM Viewer AppCarl Zeiss Meditec AGNFG2018-03-22
04987669100523Image filing softwareNIDEK CO.,LTD.NFG2016-08-26
04987669100554NON-MYDRIATIC AUTO FUNDUS CAMERANIDEK CO.,LTD.NFG2016-06-24
03596010588371N/ASmith & Nephew, Inc.NFG2016-04-12
04049471094077VISUPAC 500Carl Zeiss Meditec AGNFG2016-01-15
03596010588388INTEGRATION BROKERSmith & Nephew, Inc.NFG2015-08-29