FDA.reportPublic FDA data

Integra® Duo

Primary DI
10381780490708
Brand
Integra® Duo
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
90622
Catalog number
90622
Device description
Duo LED Lithium Ion Batteries (2/pack)
Published
2018-11-14
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
FSRLight, headband, surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780490708PrimaryGS10
00381780490701Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178049070810381780490708
00381780490701003817804907013817804907010381780490701

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
2
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
30381780039444CUSA® NXTNXT32182016-12-29
30381780039468CUSA® NXTNXT32192016-12-29
30381780039482CUSA® NXTNXT32202016-12-29
30381780040365CUSA® Selector®15232352017-01-27
30381780121972CUSA® Selector®15232152017-01-27
M610152324315CUSA® NXT15232432016-12-29
10381780040712CUSA® Selector®15230452016-12-29
10381780040408CUSA® Selector®1523072M22016-12-29
10381780039617Camino®AP062016-12-29
10381780039655Camino®AP192016-12-29
10381780536376CUSA® ClarityC7523XEAC7523XEA2023-07-14
30381780536387CUSA® ClarityC7523XC7523X2023-07-14
30381780533874CUSA® ClarityC7404SC7404S2023-06-21
30381780533898CUSA® ClarityC7404LSC7404LS2023-06-21
M273NXT800011CUSA® NXTNXT800012016-12-29
M273NXT800021CUSA® NXTNXT800022016-12-29
M273NXT800031CUSA® NXTNXT800032016-12-29
M269NXT3218EA1CUSA® NXTNXT3218EA2016-12-29
10381780039471CUSA® NXTNXT3219EA2017-01-27
10381780039495CUSA® NXTNXT3220EA2017-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10381780490944Integra® 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
00732094072174Welch Allyn, Inc.WELCH ALLYN, INC.FSR2016-09-17