KI71759

GUDID 00849771050179

Steinmann Pins, Double trocar threaded, 1/8-inch (3.2mm) diameter, 9-inch long

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00849771050179
NIH Device Record Keyf1f4574f-4a8a-4cba-b550-299fabcdf964
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberK-Wires and Steinmann Pins
Catalog NumberKI71759
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 Identifiers

Device Issuing AgencyDevice ID
GS100849771015529 [Previous]
GS100849771050179 [Unit of Use]
GS110849771050176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


[00849771050179]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-01
Device Publish Date2023-07-24

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.