AccessGUDID - DEVICE: Single Use 3-Lumen Extraction Balloon V (04953170279560)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use 3-Lumen Extraction Balloon V
Version or Model: B-V443Q-B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170279560
Issuing Agency: GS1
Commercial Distribution End Date: August 12, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: Single Use 3-Lumen Extraction Balloon V

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):	Yes
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?
46715	ERCP catheter, balloon, non-electrical, stone-retrieval	A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGE	CATHETER, BILIARY, DIAGNOSTIC
LQR	DISLODGER, STONE, BILIARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 07211ee9-02cb-4ade-a0b4-edb83f18767a
Public Version Date: August 15, 2022
Public Version Number: 4
DI Record Publish Date: September 21, 2016