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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 biopsy system negative pressure manometer FDA UDI
Model / Reference
rbi2 FDA UDI
Description
rbi2 suction biopsy system negative pressure manometer FDA UDI

Identifiers

Catalog Number
MR100 FDA UDI
Primary DI / UDI-DI
B194MR1001 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Rectal 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 7398e368-5d22-4364-bd4d-9aeaff4e45d1 36 fields · synced May 30, 2026