Key Surgical K-Wires and Steinmann Pins

GUDID 00849771045113

K-Wires, Single Trocar with Round end, 6" (15cm) long, 0.051" (1.3mm) diam

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00849771045113
NIH Device Record Key94493de7-4279-42d1-8b3c-0ea739452821
Commercial Distribution StatusIn Commercial Distribution
Brand NameKey Surgical K-Wires and Steinmann Pins
Version Model NumberKI-051-05
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

Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
Emailregulatory@keysurgical.com
Phone800.541.7995
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
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
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
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
GS100849771038085 [Primary]
GS100849771045113 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


[00849771045113]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-30
Device Publish Date2020-12-22

On-Brand Devices [Key Surgical K-Wires and Steinmann Pins]

00849771044222K-Wire, Single Trocar, 1cm partially threaded, 0.049" (1.25mm) diameter, 5.90" (150mm) length
00849771044215K-Wires, Double Blunt, .094" (2.4mm) diameter, 20" long
00849771044192K-Wires, Single trocar, .062" (1.6mm) diameter, 6" long, ASTM A967, F138, S/S 1.4441
00849771044185K-Wires, Single trocar, .054" (1.4mm) diameter, 6" long, ASTM A967, F138, S/S 1.4441
00849771044178K-Wires, Single trocar, .045" (1.1mm) diameter, 6" long, ASTM A967, F138, S/S 1.4441
00849771044161K-Wires, Single trocar, .035" (.9mm) diameter, 4" long, ASTM A967, F138, S/S 1.4441
00849771044208K-Wires, Single trocar, .062" (1.6mm) diameter, 11" long
00849771044239K-Wires, Double Blunt, .032" (0.81mm) diameter, 6" long
00849771044444K-Wires, Double trocar, .028" (.7mm) diameter, 9" long
00849771044529K-Wires, Double trocar, .054" (1.4mm) diameter, 12" long
00849771044512K-Wires, Double trocar, .062" (1.6mm) diameter, 12" long
00849771044505K-Wires, Double trocar, .045" (1.1mm) diameter, 12" long
00849771044499K-Wires, Double trocar, .035" (.9mm) diameter, 12" long
00849771044482K-Wires, Double trocar, .054" (1.4mm) diameter, 9" long
00849771044475K-Wires, Double trocar, .062" (1.6mm) diameter, 9" long
00849771044468K-Wires, Double trocar, .045" (1.1mm) diameter, 9" long
00849771044451K-Wires, Double trocar, .035" (.9mm) diameter, 9" long
00849771044437K-Wires, Double trocar, .062" (1.6mm) diameter, 5" long
00849771044420K-Wires, Double trocar, .054" (1.4mm) diameter, 5" long
00849771044413K-Wires, Double trocar, .045" (1.1mm) diameter, 5" long
00849771044406K-Wires, Double trocar, .035" (.9mm) diameter, 5" long
00849771044390K-Wires, Double trocar, .028" (.7mm) diameter, 5" long
00849771044383K-Wires, Double trocar, .054" (1.4mm) diameter, 4" long
00849771044376K-Wires, Double trocar, .062" (1.6mm) diameter, 4" long
00849771044369K-Wires, Double trocar, .045" (1.1mm) diameter, 4" long
00849771044352K-Wires, Double trocar, .035" (.9mm) diameter, 4" long
00849771044345K-Wires, Double trocar, .028" (.7mm) diameter, 4" long
00849771044338K-Wires, Double diamond, .054" (1.4mm) diameter, 6" long
00849771044321K-Wires, Double diamond, .062" (1.6mm) diameter, 6" long
00849771044314K-Wires, Double diamond, .045" (1.1mm) diameter, 6" long
00849771044307K-Wires, Double diamond, .035" (.9mm) diameter, 6" long
00849771044291K-Wires, Double diamond, .028" (.7mm) diameter, 6" long
00849771044284K-Wires, Double trocar, .062" (1.6mm) diameter, 6" long
00849771044277K-Wires, Double trocar, .054" (1.4mm) diameter, 6" long
00849771044260K-Wires, Double trocar, .045" (1.1mm) diameter, 6" long
00849771044253K-Wires, Double trocar, .035" (.9mm) diameter, 6" long
00849771044246K-Wires, Double trocar, .028" (.7mm) diameter, 6" long
00849771045168Steinmann Pins, Single Diamond, 4 Suture, 0.141" diameter, 12.0" long
00849771045151Steinmann Pins, Double trocar threaded, 0.189" (4.8mm) diameter, 9" long
00849771045144Steinmann Pins, Double trocar, 0.189" (4.8mm) diameter, 9" long
00849771045137Steinmann Pins, Single trocar, round end, .188"diameter, 9" long
00849771045908Steinmann Pins, Single Trocar with Round end, 3mm threaded, 9" (23cm) long, 0.093" (2.4mm) diam
00849771045892Steinmann Pins, Single Trocar with Round end, 9" (23cm) long, 0.093" (2.4m) diam
00849771045120K-Wires, Single Trocar with Round end, 9" (23cm) long, 0.051" (1.3mm) diam
00849771045113K-Wires, Single Trocar with Round end, 6" (15cm) long, 0.051" (1.3mm) diam
00849771045106K-Wires, Single Trocar with Round end, 6" (15cm) long, 0.039" (1.0mm) diam
00849771045090K-Wires, Single Trocar with Round end, 6" (15cm) long, 0.028" (0.7mm) diam
00849771045571Steinmann Pins, Single trocar, round end, 0.094" (2.4mm) diameter, 12" long
00849771044772K-Wires, Single trocar, .045" (1.1mm) diameter, 6" long
00849771044741K-Wires, Single trocar, .028" (.7mm) diameter, 6" long

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