C141

GUDID 50849771050631

Pin Covers, Sterile, Brown, 2 per package

KEY SURGICAL, INC.

Surgical instrument guard, single-use
Primary Device ID50849771050631
NIH Device Record Keydf1fb9dc-2e58-4ce8-92db-0a20682f3305
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberK-Wire and Pin Covers
Catalog NumberC141
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771000976 [Previous]
GS100849771050636 [Unit of Use]
GS110849771050633 [Primary]
GS150849771050631 [Package]
Contains: 10849771050633
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-09
Device Publish Date2024-08-01

Devices Manufactured by KEY SURGICAL, INC.

00849771048503 - NA2024-08-30 Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm
00849771052180 - Instrument Stringers2024-08-30 Instrument Stringer, U-Shaped Stringer, Surgical Stainless Steel, 16-inch x 2.75-inch
00849771050162 - NA2024-08-30 Steinmann Pins, Double trocar threaded, 7/64-inch (2.8mm) diameter, 9-inch long
10849771050466 - NA2024-08-09 Suture Booties, Red, Sterile, 5 pair per pad
50849771050631 - NA2024-08-09Pin Covers, Sterile, Brown, 2 per package
50849771050631 - NA2024-08-09 Pin Covers, Sterile, Brown, 2 per package
50849771050846 - NA2024-08-09 Vascular Loops, Sterile, Blue, Super Maxi, 18-inch long, 2 per package
60849771028132 - NA2024-07-24 Polypropylene Channel Brush BLUE 16 INCH L 0.039 INCH DIAMETER
60849771028149 - NA2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.039 INCH DIAMETER

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