FDA.reportPublic FDA data

AURORA® Surgiscope®

Primary DI
00850002332131
Brand
AURORA® Surgiscope®
Company
REBOUND THERAPEUTICS CORPORATION
Model
AS8/130
Catalog number
AS8/130
Device description
AURORA® Surgiscope® System
Published
2019-12-18
Public version status
Update
Distribution status
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
GTZANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
GWGEndoscope, Neurological
GZTRetractor, Self-Retaining, For Neurosurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTZAntisera, All Groups, Streptococcus Spp.Microbiology1
GWGEndoscope, NeurologicalNeurology2
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191861000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191861000Aurora Surgiscope SystemRebound Therapeutics2019-12-06GWG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002332131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002332131008500023321318500023321310850002332131

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
Length130Millimeter

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
Manufacturing 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
00860624000455AURORA® Surgiscope®AS8/100AS8/1002019-12-18
00860624000462AURORA® Surgiscope®AS8/70AS8/702019-12-18
00860624000448AURORA SurgiscopeAURORA Surgiscope-13AURORA Surgiscope-132019-01-22
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
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08800112400178cCeLLVPIX Medical, Inc.GWG2026-05-11
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10381780537854TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
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10381780537878Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537885Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537908MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
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10381780344643Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344650Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23