FDA.reportPublic FDA data

AURORA Evacuator

Primary DI
00860624000424
Brand
AURORA Evacuator
Company
REBOUND THERAPEUTICS CORPORATION
Model
AURORA Evacuator-10
Catalog number
AURORA Evacuator-10
Device description
The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remove fluids and soft tissue during minimally invasive surgical procedures.
Published
2018-05-29
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180372000Aurora EvacuatorRebound Therapeutics2018-04-09GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860624000424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860624000424008606240004248606240004240860624000424

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction systemAn assembly of devices designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a surgical site by means of suction during surgical procedures. It generally consists of a mains electricity (AC-powered) suction pump, a regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The vacuum capability should be at least 400 mm Hg; free flow rates may be as high as 35 litter/min. The system is mainly used when suction from a central vacuum system is not available or appropriate.

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
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
00860624000431AURORA EvacuatorAURORA Evacuator-7AURORA Evacuator-72018-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
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00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
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07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
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B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
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00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28