rbi2 suction rectal biopsy system SS1000

GUDID B194SS10001

rbi2 suction rectal biopsy system sterilization/storage container

AUS SYSTEMS PTY. LIMITED.

Rectal suction biopsy system

• Primary Device ID: B194SS10001
• NIH Device Record Key: 4cf08416-afef-4b38-bc44-726d71d54e42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rbi2 suction rectal biopsy system
• Version Model Number: rbi2
• Catalog Number: SS1000
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	B194SS10001 [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: false

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

[B194SS10001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-07-08
• Device Publish Date: 2016-10-24

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