AccessGUDID - DEVICE: Modular Impactor Handle (00819251024013)

GUDID

Device Identifier (DI) Information

Brand Name: Modular Impactor Handle
Version or Model: 2125.00.000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL JOINT ORTHOPEDICS, INC.

Primary DI Number: 00819251024013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078416717 *Terms of Use

Device Description: Modular Impactor Handle

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?
32856	Orthopaedic implant impactor, reusable	A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWA	Impactor

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
No Device Sizes

Device Record Status

Public Device Record Key: 0199b73c-3e0f-4cf7-b6fb-9581925d19cc
Public Version Date: February 09, 2026
Public Version Number: 5
DI Record Publish Date: November 04, 2019