FDA.reportPublic FDA data

Integra®

Primary DI
10381780168621
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
90521
Catalog number
90521
Device description
Integra® LED Battery Holster
Published
2016-09-07
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
10381780168621PrimaryGS10
M433905211SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178016862110381780168621

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).

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

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