FDA.reportPublic FDA data

AURORA Surgiscope

Primary DI
00860624000448
Brand
AURORA Surgiscope
Company
REBOUND THERAPEUTICS CORPORATION
Model
AURORA Surgiscope-13
Catalog number
AURORA Surgiscope-13
Device description
The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB). The AURORA Surgiscope includes the following parts: Sheath, Camera, LEDs (Light Emitting Diodes), Sheath Cable, and Obturator.
Published
2019-01-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWGEndoscope, Neurological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWGEndoscope, NeurologicalNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860624000448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860624000448008606240004488606240004480860624000448

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical neuroscope, single-useA sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the central nervous system (CNS). It is inserted into the body through a pre-drilled hole in the cranium for neuroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length13Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080909607
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002332049AURORA® Surgiscope®ICB/PCICB/PC2022-11-29
00850002332223AURORA®AEC12F/70AEC12F/702021-01-12
00850002332209AURORA®AEC12F/130AEC12F/1302021-01-12
00850002332216AURORA®AEC12F/100AEC12F/1002021-01-12
00850002332148AURORA®AE10F/130AE10F/1302020-02-06
00850002332155AURORA®AE10F/100AE10F/1002020-02-06
00850002332162AURORA®AE10F/70AE10F/702020-02-06
00860624000400AURORA® Surgiscope®Image Control BoxIMAGE_CONTROL_BOX2019-01-22
00850002332131AURORA® Surgiscope®AS8/130AS8/1302019-12-18
00860624000455AURORA® Surgiscope®AS8/100AS8/1002019-12-18
00860624000462AURORA® Surgiscope®AS8/70AS8/702019-12-18
00850002332001AURORA EvacuatorAURORA Evacuator-10Fx13cmAURORA Evacuator-10Fx13cm2019-04-30
00850002332063AURORA EvacuatorAURORA Evacuator-9Fx13cmAURORA Evacuator-9Fx13cm2019-04-30
00850002332070AURORA EvacuatorAURORA Evacuator-9Fx10cmAURORA Evacuator-9Fx10cm2019-04-30
00860624000417AURORA EvacuatorAURORA Evacuator-13AURORA Evacuator-132018-05-29
00850002332018AURORA EvacuatorAURORA Evacuator-10Fx10cmAURORA Evacuator-10Fx10cm2019-04-30
00850002332025AURORA EvacuatorAURORA Evacuator-10Fx7cmAURORA Evacuator-10Fx7cm2019-04-30
00850002332087AURORA EvacuatorAURORA Evacuator-9Fx7cmAURORA Evacuator-9Fx7cm2019-04-30
00860624000424AURORA EvacuatorAURORA Evacuator-10AURORA Evacuator-102018-05-29
00860624000431AURORA EvacuatorAURORA Evacuator-7AURORA Evacuator-72018-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800112400161cCeLLVPIX Medical, Inc.GWG2026-05-11
08800112400178cCeLLVPIX Medical, Inc.GWG2026-05-11
00860000321389Neuroblade SystemClearmind Biomedical Inc.GWG2026-05-11
00810004821064Clarus Digital ChannelScope Endoscope, 21.6cm, 3mm WCCLARUS MEDICAL, LLCGWG2026-04-21
00810004821071Clarus Digital ChannelScope Endoscope, 13.0cm, 3mm WCCLARUS MEDICAL, LLCGWG2026-04-21
00810004821118Digital MurphyScope EndoscopeCLARUS MEDICAL, LLCGWG2026-04-21
00840067103029ZenithCADWELL INDUSTRIES, INC.GWG2025-12-31
04048551418123n.a.Karl Storz GmbH & Co. KGGWG2025-08-11
04048438000175NAKarl Storz GmbH & Co. KGGWG2025-03-27
00810004820401Clarus Digital ChannelScope Endoscope, 21.6cm, 3.5mm ODCLARUS MEDICAL, LLCGWG2024-12-23
00810004820418Clarus Digital ChannelScope Endoscope, 21.6cmCLARUS MEDICAL, LLCGWG2024-12-23
04048551425695n.a.Karl Storz GmbH & Co. KGGWG2024-12-20
04048551436271n.a.Karl Storz GmbH & Co. KGGWG2024-11-28
10884521844681VS3 IridiumVISIONSENSE LTD.GWG2024-11-11
04048551436240n.a.Karl Storz GmbH & Co. KGGWG2024-10-18
04055207008317RIWORichard Wolf GmbHGWG2024-08-19
04055207069981RIWORichard Wolf GmbHGWG2024-08-19
10810004821016Clarus Digital Control ModuleCLARUS MEDICAL, LLCGWG2024-02-19
076133276089151788STRYKER CORPORATIONGWG2023-12-11
00850002332285Aurora® Surgiscope®Integra Lifesciences CorporationGWG2023-11-09
00850002332292Aurora® Surgiscope®Integra Lifesciences CorporationGWG2023-11-09
10884521834644VS3-IRVISIONSENSE LTD.GWG2022-05-09
00860000321310Axonpen SystemClearmind Biomedical Inc.GWG2022-02-18
00860000321334ClearPathClearmind Biomedical Inc.GWG2022-02-18
00850002332247AURORA® Surgiscope®Integra Lifesciences CorporationGWG2021-05-18
00850002332254AURORA® Surgiscope®Integra Lifesciences CorporationGWG2021-05-18
10813040013704VS3-IRVISIONSENSE LTD.GWG2020-06-11
10813040013711VS3-IRVISIONSENSE LTD.GWG2020-06-11
10813040013728VS3-IRVISIONSENSE LTD.GWG2020-06-11
10813040013117VS3-IRVISIONSENSE LTD.GWG2020-04-07