AccessGUDID - DEVICE: BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr w/bulb (10816286020635)

GUDID

Device Identifier (DI) Information

Brand Name: BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr w/bulb
Version or Model: 5236B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOEHRINGER LABORATORIES, LLC

Primary DI Number: 10816286020635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079991657 *Terms of Use

Device Description: ViSiGi 3D® Calibration System size 36Fr Std w/ Bulb

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":	Yes
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?
44686	Gastric calibration tube	A thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	Tubes, Gastrointestinal (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130483	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
Catheter Gauge: 36 French

Device Record Status

Public Device Record Key: b094fe66-8f46-43f4-9009-2833742e8485
Public Version Date: November 09, 2022
Public Version Number: 6
DI Record Publish Date: August 01, 2016