KI71123

GUDID 00849771049005

K-Wires, Double trocar, .062-inch (1.6mm) diameter, 12-inch long

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00849771049005
NIH Device Record Keyc465b23d-507a-4308-8a1e-7dafdbc65417
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberK-Wires and Steinmann Pins
Catalog NumberKI71123
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771012429 [Previous]
GS100849771049005 [Unit of Use]
GS110849771049002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

Moist Heat or Steam Sterilization


[00849771049005]

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.

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
00849771046394 - K-Wire and Steinmann Pin Dispensers2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 26
00849771013372 - Key Surgical Cautery Tip Cleaner2025-04-14 Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch
50849771050617 - NA2025-03-17 Pin Covers, Sterile, Tan, 2 per package
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.

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