AccessGUDID - DEVICE: Oracle (00816765011935)

GUDID

Device Identifier (DI) Information

Brand Name: Oracle
Version or Model: 00711891
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00711891
Company Name: US Endoscopy

Primary DI Number: 00816765011935
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: The Oracle EUS Balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the upper and lower gastrointestinal tract.

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?
62177	Ultrasound endoscope balloon, synthetic polymer	A sterile balloon-like cap made of a synthetic-polymer (e.g., silicone) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDF	Colonoscope and accessories, flexible/rigid
ITX	Transducer, ultrasonic, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111028	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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 98d71bc3-06ac-45d3-9598-be2d7ec130e0
Public Version Date: March 31, 2020
Public Version Number: 5
DI Record Publish Date: September 17, 2016