Distal Hip Reamer, Sz 18

GUDID 00810094692247

Distal Hip Reamer, Sz 18

TOTAL JOINT ORTHOPEDICS, INC.

Medullary canal orthopaedic reamer, rigid
Primary Device ID00810094692247
NIH Device Record Key93d57897-1b08-4f07-b42b-5a09afe7a9de
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Hip Reamer, Sz 18
Version Model Number1349.18.000
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-486-6070
Emailkcardall@tjoinc.com
Phone801-486-6070
Emailkcardall@tjoinc.com
Phone801-486-6070
Emailkcardall@tjoinc.com
Phone801-486-6070
Emailkcardall@tjoinc.com
Phone801-486-6070
Emailkcardall@tjoinc.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810094692247 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810094692247]

Moist Heat or Steam Sterilization


[00810094692247]

Moist Heat or Steam Sterilization


[00810094692247]

Moist Heat or Steam Sterilization


[00810094692247]

Moist Heat or Steam Sterilization


[00810094692247]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-30
Device Publish Date2025-01-22

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

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00810094692155 - Distal Hip Reamer, Sz 82025-01-30 Distal Hip Reamer, Sz 8
00810094692162 - Distal Hip Reamer, Sz 92025-01-30 Distal Hip Reamer, Sz 9
00810094692179 - Distal Hip Reamer, Sz 102025-01-30 Distal Hip Reamer, Sz 10
00810094692186 - Distal Hip Reamer, Sz 112025-01-30 Distal Hip Reamer, Sz 11
00810094692193 - Distal Hip Reamer, Sz 122025-01-30 Distal Hip Reamer, Sz 12
00810094692209 - Distal Hip Reamer, Sz 132025-01-30 Distal Hip Reamer, Sz 13

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