FDA.reportPublic FDA data

Integra®

Primary DI
10381780168607
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
90520US
Catalog number
90520US
Device description
Integra® LED Headlight with Batteris & AC/DC Power Supply - US
Published
2016-08-31
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
10381780168607PrimaryGS10
M43390520US1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178016860710381780168607

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
Special Storage Condition, Specify00Storage/Transport Temperature: -20 C to 49 C (-4 F to 120 F); Storage Transport Humidity: 30% to 80% Relative Humidity, non-condensing

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11
10381780154501Integra® Ruggles®-Redmond™R2382R23822016-08-11
10381780154518Integra® Ruggles®-Redmond™R2384R23842016-08-11
10381780154525Integra® Ruggles®-Redmond™R2389R23892016-08-11
10381780154532Integra® Ruggles®-Redmond™R2396R23962016-08-11
10381780154549Integra® Ruggles®-Redmond™R2397R23972016-08-11

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
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