FDA.reportPublic FDA data

INTEGRATION BROKER

Primary DI
03596010588388
Brand
INTEGRATION BROKER
Company
Smith & Nephew, Inc.
Model
72201082
Catalog number
72201082
Device description
INTEGRATION BROKER ANNUAL SUPPORT DICO
Published
2015-08-29
Public version status
Update
Distribution status
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
03596010588388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010588388035960105883883596010588388

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)821-5700gudid@smith-nephew.com

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010469182GENESIS II71421012714210122015-08-30
03596010469212GENESIS II71421015714210152015-08-30
03596010469229GENESIS II71421016714210162015-08-30
03596010469236GENESIS II71421017714210172015-08-30
03596010469267GENESIS II71421112714211122015-08-30
03596010469274GENESIS II71421113714211132015-08-30
03596010469281GENESIS II71421114714211142015-08-30
03596010469298GENESIS II71421115714211152015-08-30
03596010469304GENESIS II71421116714211162015-08-30
03596010469328GENESIS II71421118714211182015-08-30
03596010531018JOURNEY74024629740246292015-08-29
03596010531025JOURNEY74024632740246322015-08-29
03596010554468JOURNEY74024623740246232015-08-29
03596010554475JOURNEY74024626740246262015-08-29
03596010554512JOURNEY74024826740248262015-08-29
03596010554529JOURNEY74024829740248292015-08-29
03596010554536JOURNEY74024832740248322015-08-29
03596010000675OXINIUM71343603713436032015-08-30
03596010469199GENESIS II71421013714210132015-08-30
03596010469205GENESIS II71421014714210142015-08-30

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
03596010589637INTEGRATION BROKERSmith & Nephew, Inc.NFG2016-04-12
03596010588371N/ASmith & Nephew, Inc.NFG2016-04-12
04049471094077VISUPAC 500Carl Zeiss Meditec AGNFG2016-01-15