KI71303

GUDID 00849771049524

K-Wires, Double trocar, threaded, .062-inch (1.6mm) diameter, 9-inch long

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00849771049524
NIH Device Record Keyabb592e4-c0ef-4923-9780-bee254d60c55
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberK-Wires and Steinmann Pins
Catalog NumberKI71303
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

Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch
Guidewire Length9 Inch
Guidewire Diameter0.062 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771012924 [Previous]
GS100849771049524 [Unit of Use]
GS110849771049521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

Moist Heat or Steam Sterilization

[00849771049524]

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.

00849771047643 - NA2024-04-01 Instrument Stringers, Center Lock Stringer, Surgical Stainless Steel, 6-inch x 3-inch
00849771048077 - NA2024-04-01 German Stainless Steel Pliers, Locking Pliers, 8-inch medium
00849771048220 - NA2024-04-01 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 12-inch long
00849771048244 - NA2024-04-01 K-Wire and Steinmann Pin Dispensers, 3/32-inch (2.4mm) diameter, Holds pins up to 12-inch long
10849771050473 - NA2024-04-01 Suture Booties, White, Sterile, 5 pair per pad
00849771051275 - NA2024-04-01 Endoscope Brush, 150cm long, 4.2mm dia, 2cm BAL, Nylon Bristles, pink polypropylene tubing
00849771051534 - Key Surgical Endoscope Brushes2024-04-01 Specialty Cleaning Brushes, nylon, ss spring coil wire, 3-5mm tapered, bead
00849771051619 - Key Surgical Endoscope Brushes2024-04-01 Specialty Cleaning Brushes, Nylon bristles on both ends, rigid plastic tubing, 3-5 mm tapered diameter
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