KI71030

GUDID 00849771048787

K-Wires, Double diamond, .028-inch (.7mm) diameter, 6-inch long

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00849771048787
NIH Device Record Keye77ed89a-caf1-4e68-8ee5-5db78ff5d4c6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberK-Wires and Steinmann Pins
Catalog NumberKI71030
Company DUNS604056226
Company NameKEY SURGICAL, INC.
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com
Phone+1(800)541-7995
Emailregulatory@keysurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771012139 [Previous]
GS100849771048787 [Unit of Use]
GS110849771048784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


[00849771048787]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-01
Device Publish Date2024-03-22

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60849771028224 - NA2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.105 INCH DIAMETER

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