Universal Cone Impactor Head

GUDID 00810094692278

Cone Impactor Head, Size 1-2, 12°

TOTAL JOINT ORTHOPEDICS, INC.

Orthopaedic implant impactor, reusable
Primary Device ID00810094692278
NIH Device Record Key7f4925ef-4b7a-4fd0-88cd-a9991d16e30b
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Cone Impactor Head
Version Model Number2021.12.012
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100810094692278 [Primary]

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


[00810094692278]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-02
Device Publish Date2025-04-24

On-Brand Devices [Universal Cone Impactor Head]

00810094692292Cone Impactor Head, Size 5-7, 24°
00810094692285Cone Impactor Head, Size 3-4, 18°
00810094692278Cone Impactor Head, Size 1-2, 12°

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