FDA.reportPublic FDA data

Integra®

Primary DI
10381780356561
Brand
Integra®
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
003285BKT
Catalog number
003285BKT
Device description
Integra® Fixed Focus Headlight Camera System Monitoring Bracket
Published
2020-01-13
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
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
10381780356561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178035656110381780356561

GMDN Terms#

Term, Definition table
TermDefinition
Operating light systemAn assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

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
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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
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
H8346009600Integra®INTEGRA LIFESCIENCES (IRELAND) LIMITEDFWC2018-10-23
M933MDF20010460Medical Facets NCMEDICAL FACETS NC LLCFWC2015-10-12