FDA.reportPublic FDA data

AURORA Evacuator

Primary DI
00860624000417
Brand
AURORA Evacuator
Company
REBOUND THERAPEUTICS CORPORATION
Model
AURORA Evacuator-13
Catalog number
AURORA Evacuator-13
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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860624000417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860624000417008606240004178606240004170860624000417

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical suction system, vacuumAn assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.

Contacts#

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

Regulatory Flags#

DUNS number
080909607
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002332001AURORA EvacuatorAURORA Evacuator-10Fx13cmAURORA Evacuator-10Fx13cm2019-04-30
00850002332018AURORA EvacuatorAURORA Evacuator-10Fx10cmAURORA Evacuator-10Fx10cm2019-04-30
00850002332025AURORA EvacuatorAURORA Evacuator-10Fx7cmAURORA Evacuator-10Fx7cm2019-04-30
00850002332063AURORA EvacuatorAURORA Evacuator-9Fx13cmAURORA Evacuator-9Fx13cm2019-04-30
00850002332070AURORA EvacuatorAURORA Evacuator-9Fx10cmAURORA Evacuator-9Fx10cm2019-04-30
00850002332087AURORA EvacuatorAURORA Evacuator-9Fx7cmAURORA Evacuator-9Fx7cm2019-04-30
00860624000424AURORA EvacuatorAURORA Evacuator-10AURORA Evacuator-102018-05-29
00860624000431AURORA EvacuatorAURORA Evacuator-7AURORA Evacuator-72018-05-29
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

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Primary DI, Brand, Company table
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B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
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B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
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00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
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00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
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00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
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00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13