FDA.reportPublic FDA data

rbi2 suction rectal biopsy system

Primary DI
B194CP12001
Brand
rbi2 suction rectal biopsy system
Company
AUS SYSTEMS PTY. LIMITED.
Model
rbi2
Catalog number
CP1200
Device description
rbi2 suction rectal biopsy procedure pack
Published
2016-08-29
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

Product Codes#

Code, Name table
CodeName
FCKInstrument, Biopsy, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCKInstrument, Biopsy, SuctionGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062159000RB12 SUCTION RECTAL BIOPSY SYSTEMAus Systems Pty , Ltd.2006-09-05FCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B194CP12002PackageHIBCC10In Commercial Distribution
B194CP12001PrimaryHIBCC0
B194CP12000Unit of UseHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Regulatory Flags#

DUNS number
755219508
Device count
3
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B194SS10001rbi2 suction rectal biopsy system rbi2SS10002016-10-24
B194HP10001rbi2 suction rectal biopsy systemrbi2HP10002016-10-24
B194MR1001rbi2 suction rectal biopsy systemrbi2MR1002016-08-29
CP12000rbi2 suction rectal biopsy systemrbi2CP12002016-08-29
CP12001rbi2 suction rectal biopsy systemrbi2CP12002016-08-29
CP12002rbi2 suction rectal biopsy systemrbi2CP12002016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FCK2021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FCK2021-08-13
B194HP10001rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-10-24
B194SS10001rbi2 suction rectal biopsy system AUS SYSTEMS PTY. LIMITED.FCK2016-10-24
09340254000632TREWAVIS SURGICALTREWAVIS SURGICAL INSTRUMENTS PTY LTDFCK2016-10-20
00827002217911HowellCOOK INCORPORATEDFCK2016-09-24
B194MR1001rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-08-29
CP12000rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-08-29
CP12001rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-08-29
CP12002rbi2 suction rectal biopsy systemAUS SYSTEMS PTY. LIMITED.FCK2016-08-29