AccessGUDID - DEVICE: Infinity (00816765011782)

GUDID

Device Identifier (DI) Information

Brand Name: Infinity
Version or Model: 00711652
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00711652
Company Name: US Endoscopy

Primary DI Number: 00816765011782
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 disposable Infinity ERCP sampling device is used to retrieve cytological cell samples in the 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?
38834	Flexible endoscopic cytology brush, single-use	A device intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDX	endoscopic cytology brush

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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 3 Millimeter

Device Record Status

Public Device Record Key: c86e56c9-ae11-46f4-9918-86553d67da3f
Public Version Date: March 31, 2020
Public Version Number: 5
DI Record Publish Date: September 17, 2016