AccessGUDID - DEVICE: Orthex (00841731119209)

GUDID

Device Identifier (DI) Information

Brand Name: Orthex
Version or Model: ORTHEXRPS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: VILEX IN TENNESSEE, INC.

Primary DI Number: 00841731119209
Issuing Agency: GS1
Commercial Distribution End Date: April 26, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 152008371 *Terms of Use

Device Description: Orthex P&C Software

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?
58120	External orthopaedic fixation frame calculation software	A stand-alone software application designed provide algorithms to assist a physician/surgeon in performing calculations to help create a schedule for the regular adjustment of an external orthopaedic fixation frame (framework) to help facilitate optimum bone growth for fracture healing. This software performs the necessary mathematical calculations and may provide a visual example of the skeletal deformities. It is intended to be installed on an off-the-shelf computer/smart device as an aid to the clinical judgement of a physician/surgeon in a clinic or hospital environment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
OSN	Software For Diagnosis/Treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151881	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
No Device Sizes

Device Record Status

Public Device Record Key: e0875c76-caa8-4691-b0c3-eefb62a154b9
Public Version Date: December 22, 2021
Public Version Number: 10
DI Record Publish Date: June 23, 2017

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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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