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rbi2 suction rectal biopsy system

FDA UDI

Class II (US FDA UDI)

by Aus Systems Pty , Ltd.

Identity

Trade Name
rbi2 suction rectal biopsy system FDA UDI
Generic Name
Rectal suction biopsy system FDA UDI
Device Name
rbi2 suction rectal biopsy system sterilization/storage container FDA UDI
Model / Reference
rbi2 FDA UDI
Description
rbi2 suction rectal biopsy system sterilization/storage container FDA UDI

Identifiers

Catalog Number
SS1000 FDA UDI
Primary DI / UDI-DI
B194SS10001 FDA UDI
510(k) Number
K062159 FDA UDI
FDA Product Code
FCK FDA UDI
GMDN Term
Rectal suction biopsy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1075 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Device sterilization/disinfection container, reusableRectal suction biopsy system

rbi2 suction rectal biopsy system by Aus Systems Pty , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rectal suction biopsy system.

Cleared under the same submission

K062159 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aus Systems Pty , Ltd.

Sources (1)

  • FDA UDI 4cf08416-afef-4b38-bc44-726d71d54e42 35 fields · synced Jun 1, 2026