Torque Limiting Handle CTH-001

GUDID 10855068008379

A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant into the pelvis without exerting excess torque or force on the implant.

Curvafix Inc

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Primary Device ID10855068008379
NIH Device Record Keyab1747e5-eddf-4ace-b203-1bd7bd6d8fe5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTorque Limiting Handle
Version Model NumberCTH-001
Catalog NumberCTH-001
Company DUNS039779098
Company NameCurvafix Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110855068008379 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

[10855068008379]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-19
Device Publish Date2021-08-11

On-Brand Devices [Torque Limiting Handle]

10855068008379A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant into the pelvis wi
10855068008430A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant into the pelvis wi
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