AccessGUDID - DEVICE: Simple Gap Block, Straight (00819251024709)

GUDID

Device Identifier (DI) Information

Brand Name: Simple Gap Block, Straight
Version or Model: 2222.02.008
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL JOINT ORTHOPEDICS, INC.

Primary DI Number: 00819251024709
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078416717 *Terms of Use

Device Description: Simple Gap Block, Straight, Size 2, 8-10mm thickness

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?
46480	Orthopaedic knee-balance analyser, non-electrical	A mechanical orthopaedic device intended for measurement of the forces within the knee joint during a total knee arthroplasty (TKA) to assist with further planning of the procedure. It is typically a spring-loaded device with paddles to push against the adjacent joint surfaces and scales to display a force reading. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: The Klassic Knee System should be stored in a clean, dry location at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size 2, 8-10mm thickness

Device Record Status

Public Device Record Key: 300e8713-8230-413d-a6e3-f012a6ee3905
Public Version Date: November 20, 2024
Public Version Number: 2
DI Record Publish Date: November 04, 2019