FDA.reportPublic FDA data

Integra® Duo

Primary DI
10381780490944
Brand
Integra® Duo
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
90634US
Catalog number
90634US
Device description
Integra® Duo Duo 4 Bay Power Kit with Two Batteries, Charger, Power Supply, Charger Cord & Holster - US
Published
2018-11-14
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
FSRLight, headband, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSRLight, Headband, SurgicalOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780490944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178049094410381780490944

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure500 millibar1060 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius49 Degrees Celsius
Special Storage Condition, Specify00Keep Dry
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius49 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
989925396
Device count
1
Premarket exempt
true
Kit
true
Serial number
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
08404535020120Brasseler EZXIMEDICOM CO., LTD.FSR2025-10-10
00848657071017Light, Headband, SurgicalNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FSR2023-10-12
00732094004564Welch Allyn, Inc.WELCH ALLYN, INC.FSR2022-05-19
00732094004571Welch Allyn, Inc.WELCH ALLYN, INC.FSR2022-05-19
10381780490708Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490715Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490746Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490784Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490821Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490869Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490906Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780490982Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780491026Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780491064Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780491071Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780491088Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
10381780491095Integra® DuoINTEGRA LIFESCIENCES (IRELAND) LIMITEDFSR2018-11-14
04048551124444n.a.Karl Storz GmbH & Co. KGFSR2016-09-23
04048551124468n.a.Karl Storz GmbH & Co. KGFSR2016-09-23
00732094072150Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-21
00732094072167Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-21
00732094073065Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-21
00732094073072Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-21
00732094002485Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-20
00732094072143Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-20
00732094001679Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17
00732094002492Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17
00732094002591Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17
00732094041835Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17
00732094071818Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17