AccessGUDID - DEVICE: rbi2 suction rectal biopsy system (B194CP12001)

GUDID

Device Identifier (DI) Information

Brand Name: rbi2 suction rectal biopsy system
Version or Model: rbi2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CP1200
Company Name: AUS SYSTEMS PTY. LIMITED.

Primary DI Number: B194CP12001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 755219508 *Terms of Use

Device Description: rbi2 suction rectal biopsy procedure pack

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58392	Rectal suction biopsy system	An assembly of disposable and reusable devices designed to obtain a submucosal tissue specimen from the rectum using suction [rectal suction biopsy (RSB)], typically for histopathological analysis [e.g., to help diagnose Hirschsprung's disease (HD)]. It typically consists of dedicated disposable capsules (e.g., plastic cylinder-shaped devices with a small hole at their closed end that contain a metallic cutting blade), suction tubing with negative pressure manometers, and a reusable handpiece.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCK	Instrument, Biopsy, Suction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062159	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac62d7a7-8b3a-49ed-9bf7-6c444925c27f
Public Version Date: November 24, 2020
Public Version Number: 4
DI Record Publish Date: August 29, 2016