AccessGUDID - DEVICE: NOMAD Pro 2™ (EKAV085000260)

GUDID

Device Identifier (DI) Information

Brand Name: NOMAD Pro 2™
Version or Model: 0.850.0026
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FP 0190 HSC
Company Name: ARIBEX, INC.

Primary DI Number: EKAV085000260
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 169065526 *Terms of Use

Device Description: Handheld X-ray

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:	No
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?
37607	Diagnostic x-ray system generator, hand-held	An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a hand-held x-ray system, e.g., a system that is held during operation. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It includes transformer and inverter generator designs. A hand-held x-ray system generators typically comprises a control assembly (console) and high voltage transformer assembly, but can also be a mono-tank generator design.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHD	UNIT, X-RAY, EXTRAORAL WITH TIMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081664	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
Handling Environment Temperature: between -5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e38e8ac1-beb1-40a5-adaa-8abb20079294
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +18663405522
Email: support@aribex.com

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