AccessGUDID - DEVICE: Gendex GXS-700™ intraoral sensor (EKAV100810810)

GUDID

Device Identifier (DI) Information

Brand Name: Gendex GXS-700™ intraoral sensor
Version or Model: 1.008.1081
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 112 1434G1
Company Name: GENDEX CORP.

Primary DI Number: EKAV100810810
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 144575763 *Terms of Use

Device Description: Size 2, 100 Count

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?
61049	Instrument/equipment drape, single-use, non-sterile	A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MMP	Cover, barrier, protective

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 15a76537-df30-4a3f-87b6-2ff047bebb63
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016