KI71615

GUDID 00849771049852

Steinmann Pins, Double diamond, .1563 inch (4.0mm) diameter, 9-inch (22.86cm) long

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00849771049852
NIH Device Record Key45e88ccb-b170-463a-be88-cf945db8c583
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberK-Wires and Steinmann Pin
Catalog NumberKI71615
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

Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter
Length4 Centimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771014973 [Previous]
GS100849771049852 [Unit of Use]
GS110849771049859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

Moist Heat or Steam Sterilization


[00849771049852]

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.

00849771048169 - NA2025-05-08 K-Wire and Steinmann Pin Dispensers, .035 inch .9mm diameter, Holds kwires up to 6 inch long
00849771049012 - NA2025-05-08 K-Wires, Double trocar, .054-inch (1.4mm) diameter, 12-inch long
00849771049128 - NA2025-05-08 K-Wires, Single trocar, .035-inch (.9mm) diameter, 12-inch long
60849771050416 - Electro Lube2025-05-02 Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
00849771046356 - K-Wire and Steinmann Pin Dispensers2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 20
00849771046363 - K-Wire and Steinmann Pin Dispensers2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 22
00849771046370 - K-Wire and Steinmann Pin Dispensers2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 24
00849771046387 - K-Wire and Steinmann Pin Dispensers2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 25

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