AccessGUDID - DEVICE: Panel PC (05065012584516)

GUDID

Device Identifier (DI) Information

Brand Name: Panel PC
Version or Model: PC001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EVENTUM ORTHOPAEDICS LTD

Primary DI Number: 05065012584516
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 226230358 *Terms of Use

Device Description: Medical computer loaded with Quadsense 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?
62563	Arthroplasty force sensor display unit	An electrically-powered electronic device designed to wirelessly connect to an arthroplasty force sensor to display sensor readings in a graphical representation to facilitate assessment of bone resection lines and/or size or positioning of prosthesis components to be implanted. It consists of a computing device with installed dedicated application software, which may have a dedicated receiver.	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 [?]
K241298	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
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: addef1c8-6b4e-47dd-8869-3aafbfebc842
Public Version Date: January 30, 2025
Public Version Number: 1
DI Record Publish Date: January 22, 2025

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +442045428754
Email: regulatory@eventumortho.com

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