KI71016

GUDID 00849771048220

K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 12-inch long

KEY SURGICAL, INC.

Orthopaedic bone pin container
Primary Device ID00849771048220
NIH Device Record Keyce2d9686-3d08-4809-b130-4106ef68ba69
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberK-Wire and Steinmann Pin Dispensers
Catalog NumberKI71016
Company DUNS604056226
Company NameKEY SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771012054 [Previous]
GS100849771048220 [Primary]

FDA Product Code

MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


[00849771048220]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-01
Device Publish Date2024-03-22

Devices Manufactured by KEY SURGICAL, INC.

00849771052159 - NA2025-08-27 Dry Endoscopy Sponge, 2-inch OD x 0.50-inch ID x 3.75-inch Long
00849771048237 - NA2025-08-19 K-Wire and Steinmann Pin Dispensers, 5/64-inch (2.0mm) diameter, Holds pins up to 12-inch long
00849771049036 - NA2025-08-19 K-Wires, Single trocar, .035-inch (.9mm) diameter, 4-inch long
00849771049289 - NA2025-08-19 K-Wires, Single trocar, .062-inch (1.6mm) diameter, 6-inch long
00849771049500 - NA2025-08-19 K-Wires, Single diamond, round end, .062-inch (1.6mm) diameter, 12-inch
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

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