AccessGUDID - DEVICE: Klassic BiPolar Sizing Plate (00819251021340)

GUDID

Device Identifier (DI) Information

Brand Name: Klassic BiPolar Sizing Plate
Version or Model: 1320.00.000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL JOINT ORTHOPEDICS, INC.

Primary DI Number: 00819251021340
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078416717 *Terms of Use

Device Description: BiPolar Sizing Plate

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?
60385	Atrial septal defect sizing plate	A sterile, plastic plate containing a series of holes of varying diameters intended to be used to measure the diameter of an inflated sizing balloon of a cardiac catheter to assist in determining the size of an atrial septal defect. It is typically used during transcatheter closure of the defect by positioning the balloon within the defect, recording the amount of fluid required to fill the balloon to the size of the defect, then refilling the balloon outside the body and passing it through the various holes of the plate to determine the diameter. This is a single-use 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 HD Hip System should be stored in a clean, dry location at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c2fd579d-a2ab-4427-8427-92301178bb99
Public Version Date: December 12, 2023
Public Version Number: 2
DI Record Publish Date: October 21, 2019