FDA.reportPublic FDA data

Integra®

Primary DI
H8346009600
Brand
Integra®
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
600960
Catalog number
600960
Device description
Assembly, Cable S-Video 25 foot, Male/Male Connectors
Published
2018-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWCCAMERA, TELEVISION, SURGICAL, WITH AUDIO

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWCCamera, Television, Surgical, With AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780509189PrimaryGS10
H8346009600SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178050918910381780509189

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
989925396
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780039570Camino®PMIOMPM1PMIOMPM-12016-12-29
10381780533870CUSA® ClarityC7404SC7404S2023-06-21
10381780533894CUSA® ClarityC7404LSC7404LS2023-06-21
10381780536369CUSA® ClarityC7421SC7421S2022-11-15
10381780536383CUSA® ClarityC7523XC7523X2023-07-14
10381780536376CUSA® ClarityC7523XEAC7523XEA2023-07-14
10381780536352CUSA® ClarityC7421SEAC7421SEA2022-11-15
10381780533863CUSA® ClarityC7404SEAC7404SEA2022-09-06
10381780533887CUSA® ClarityC7404LSEAC7404LSEA2022-09-06
10381780026075CUSA® ExcelC4616SC4616S2016-12-29
10381780026082CUSA® ExcelC4617SC4617S2016-12-29
10381780248248CUSA® ExcelC4604ELTUS2016-12-29
10381780031659CUSA® ExcelC4617SEAC4617SEA2016-12-29
10381780466291Integra®PMIOMPM-1PMIOMPM-12018-05-30
10381780250074Licox®BC10PMOBC10PMO2016-08-02
10381780250043Licox®PMOCABPMOCAB2016-08-02
10381780121893Camino®BAT10012016-12-29
10381780039556Camino®CAMCABL2016-12-29
10381780121886Camino®EXPORTCABEXPORTCAB2016-12-29
10381780121879Camino®MONPWRMONPWR2016-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260154540234OTOPRONTHappersberger Otopront GmbHFWC2024-12-02
04260154540241OTOPRONTHappersberger Otopront GmbHFWC2024-12-02
00860008848925VoirElite 4K 31.5 Surgical DisplayJam-Labs Corp.FWC2024-01-15
04260154546656OTOPRONTHappersberger Otopront GmbHFWC2023-07-04
04260154546663OTOPRONTHappersberger Otopront GmbHFWC2023-07-04
10381780356561Integra®INTEGRA LIFESCIENCES (IRELAND) LIMITEDFWC2020-01-13
10381780356585Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFWC2020-01-13
10381780356608Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFWC2020-01-13
10381780356622Integra®INTEGRA LIFESCIENCES (IRELAND) LIMITEDFWC2020-01-13
10381780356646Integra®INTEGRA LIFESCIENCES (IRELAND) LIMITEDFWC2020-01-13
10381780509189Integra®INTEGRA LIFESCIENCES (IRELAND) LIMITEDFWC2018-10-23
M933MDF20010460Medical Facets NCMEDICAL FACETS NC LLCFWC2015-10-12