KI71200

GUDID 00849771049302

K-Wires, Double diamond, .028-inch (0.7mm) diameter, 4-inch (10cm) long

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00849771049302
NIH Device Record Key77a6816a-f156-40ba-bf44-d0ed0b27d30a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberK-Wires and Steinmann Pin
Catalog NumberKI71200
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

Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter
Outer Diameter0.7 Millimeter
Length10 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771012689 [Previous]
GS100849771049302 [Unit of Use]
GS110849771049309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

Moist Heat or Steam Sterilization


[00849771049302]

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.

00849771048503 - NA2024-08-30 Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm
00849771052180 - Instrument Stringers2024-08-30 Instrument Stringer, U-Shaped Stringer, Surgical Stainless Steel, 16-inch x 2.75-inch
00849771050162 - NA2024-08-30 Steinmann Pins, Double trocar threaded, 7/64-inch (2.8mm) diameter, 9-inch long
10849771050466 - NA2024-08-09 Suture Booties, Red, Sterile, 5 pair per pad
50849771050631 - NA2024-08-09 Pin Covers, Sterile, Brown, 2 per package
50849771050846 - NA2024-08-09 Vascular Loops, Sterile, Blue, Super Maxi, 18-inch long, 2 per package
60849771028132 - NA2024-07-24 Polypropylene Channel Brush BLUE 16 INCH L 0.039 INCH DIAMETER
60849771028149 - NA2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.039 INCH DIAMETER

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