SwitchPoint Infinity, iSuite

Primary DI
07613327054156
Brand
SwitchPoint Infinity, iSuite
Company
STRYKER COMMUNICATIONS INC.
Model
0678001000
Catalog number
0678-001-000
Device description
Infinity 3, Video Router
Published
2016-09-23
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
OCSEndoscopic video imaging system/component, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCSEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100852000STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000Stryker Communications2010-05-06OCS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327054156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327054156076133270541567613327054156

GMDN Terms#

Term, Definition table
TermDefinition
Operating room audiovisual data/device management systemA mains electricity (AC-powered) device assembly designed to provide operating room (OR) staff with a single point of management to operate electromechanical/electronic medical devices of different makes during surgery. It is a computer-based integrated hardware/software application that typically consists of a base unit (outside the sterile field or the OR) to which all device cabling is connected, and software that runs on an off-the-shelf computer with a touchscreen (in the OR). The system is intended to manipulate devices such as OR lights, OR tables, cameras, video endoscope images, and monitors; it may also be used to manage patient data from these devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)726-3705SCC-CS2@stryker.com

Regulatory Flags#

DUNS number
078807493
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327661194In-Light CameraP59109P591092025-08-27
07613327054507FLEXIS068240050006824005002023-06-07
07613327061178Visum BladeP22310P223102016-09-23
07613327054286NA068200028006820002802020-07-29
07613327054293NA068200028106820002812020-07-29
07613327166712NA068200085206820008522020-07-29
07613327166736NA068200085006820008502020-07-29
07613327589344OPERONOZ 7580275OZ 75802752022-03-22
07613327394931OPERONOZ 7552475OZ 75524752019-01-24
07613327395037OPERONOZ 7552075OZ 75520752019-01-24
07613327395068OPERONOZ 7561075OZ 75610752019-01-24
07613327395082OPERONOZ 7552275OZ 75522752019-01-24
07613327395099OPERONOZ 7569075OZ 75690752019-01-24
07613327395136OPERONOZ 7568875OZ 75688752019-01-24
07613327054330Visum068200125206820012522016-09-23
07613327054347Visum068200125306820012532016-09-23
07613327054415Visum068240013706824001372016-09-23
07613327054422Visum068240013806824001382016-09-23
07613327061185Visum Blade, iSuiteP22309P223092016-09-30
07613327384505OPERONOZ 7559275OZ 75592752019-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00874485003210UNITY 9100COGENTIX MEDICAL, INC.OCS2018-12-20
00874485003227UNITY 9000COGENTIX MEDICAL, INC.OCS2018-12-20
07613327303605Switchpoint InfinitySTRYKER COMMUNICATIONS INC.OCS2016-11-07
07613327054255SwitchPoint Infinity, iSuiteSTRYKER COMMUNICATIONS INC.OCS2016-09-23