C188

GUDID 50849771050655

Pin Covers, Sterile, Orange, 0.177-inch, 2 per package

KEY SURGICAL, INC.

Surgical instrument guard, single-use
Primary Device ID50849771050655
NIH Device Record Keya016b103-342a-4548-b56c-409a0822700a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberK-Wire and Pin Covers
Catalog NumberC188
Company DUNS604056226
Company NameKEY SURGICAL, INC.
Device Count2
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
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

Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch
Lumen/Inner Diameter0.177 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771000723 [Previous]
GS100849771050650 [Unit of Use]
GS110849771050657 [Primary]
GS150849771050655 [Package]
Contains: 10849771050657
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-11
Device Publish Date2024-10-03

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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