rbi2 suction rectal biopsy system CP1200

GUDID CP12001

rbi2 suction rectal biopsy procedure pack to obtain a submucosal tissue specimen from the rectum.

AUS SYSTEMS PTY. LIMITED.

Rectal suction biopsy system

• Primary Device ID: CP12001
• NIH Device Record Key: ac62d7a7-8b3a-49ed-9bf7-6c444925c27f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rbi2 suction rectal biopsy system
• Version Model Number: rbi2
• Catalog Number: CP1200
• Company DUNS: 755219508
• Company Name: AUS SYSTEMS PTY. LIMITED.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	CP12001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062159

FDA Product Code

• FCK: Instrument, Biopsy, Suction

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[CP12001]

Radiation Sterilization

[CP12001]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-29

On-Brand Devices [rbi2 suction rectal biopsy system]

• CP12002: rbi2 suction rectal biopsy capsules (10 procedure packs) to obtain a submucosal tissue specimen
• CP12001: rbi2 suction rectal biopsy procedure pack to obtain a submucosal tissue specimen from the rectum
• CP12000: rbi2 suction rectal biopsy capsule to obtain a submucosal tissue specimen from the rectum
• B194SS10001: rbi2 suction rectal biopsy system sterilization/storage container