AccessGUDID - DEVICE: VERASENSE (00816818020594)

GUDID

Device Identifier (DI) Information

Brand Name: VERASENSE
Version or Model: VERASENSE for Biomet Vanguard CR size 79/83
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BMT-VGCR 79
Company Name: ORTHOSENSOR INC

Primary DI Number: 00816818020594
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 005788130 *Terms of Use

Device Description: No description.

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?
58988	Arthroplasty force sensor	An electronic device designed for use during arthroplasty to facilitate assessment of joint function during implantation of prosthesis components, typically to evaluate bone resection lines, prosthesis size and positioning, and/or soft tissue tension. It is dedicated to a specific joint or type of prosthesis (e.g., total knee, reverse shoulder) and consists of a transducer pad for insertion between opposing joint surfaces. It may have an integrated digital display or communicate with an external display unit; some types include a noninvasive analogue-to-digital converter and image display controller. It is typically available as a left or right version. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONN	Intraoperative Orthopedic Joint Assessment Aid

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 Atmospheric Pressure: between 36 and 106 KiloPascal
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 47 and 106 KiloPascal
Handling Environment Humidity: between 30 and 100 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 37 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55f33a6e-df8e-45c7-b18d-8ae3b929c8de
Public Version Date: July 31, 2023
Public Version Number: 8
DI Record Publish Date: April 21, 2017