Steerable Guide Sleeve CGS-001

GUDID 10855068008225

A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation procedure to facilitate the acceptance of a Steerable Guide through it.

Curvafix Inc

Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable
Primary Device ID10855068008225
NIH Device Record Key458c6acd-337a-49c8-be09-93b377d4f4a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteerable Guide Sleeve
Version Model NumberCGS-001
Catalog NumberCGS-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 Batchtrue
Serial Numberfalse
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
GS110855068008225 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument
HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

Moist Heat or Steam Sterilization

[10855068008225]

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 [Steerable Guide Sleeve]

10855068008225A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation
10855068008478A hand-held stainless steel tube used during a CurvaFix procedure to facilitate the acceptance o
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