KI71033

GUDID 00849771048817

K-Wires, Double diamond, .062-inch (1.6mm) diameter, 6-inch (15cm) long

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00849771048817
NIH Device Record Key430e45ad-49c4-4a9b-95a4-a704a4529845
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberK-Wires and Steinmann Pin
Catalog NumberKI71033
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
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 Dimensions

Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter
Length15 Centimeter
Outer Diameter1.6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771012160 [Previous]
GS100849771048817 [Unit of Use]
GS110849771048814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


[00849771048817]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-07
Device Publish Date2023-01-26

Devices Manufactured by KEY SURGICAL, INC.

10724995225022 - Electro Lube2024-10-11 Electro Lube NXT is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
00849771048190 - NA2024-10-11 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 6-inch long
00849771052562 - Key Surgical Pipe Cleaners2024-10-11 Pipe Cleaner, 1/8-inch Cotton, 50 feet
00849771050131 - NA2024-10-11 Steinmann Pins, Double diamond, threaded, .177-inch (4.5mm) diameter, 9-inch long
50849771050563 - NA2024-10-11 K-Wire Covers, Sterile, White, 2 per package
50849771050624 - NA2024-10-11 Pin Covers, Sterile, Lavender, 2 per package
50849771050655 - NA2024-10-11 Pin Covers, Sterile, Orange, 0.177-inch, 2 per package
00849771048503 - NA2024-08-30 Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.