VL202

GUDID 50849771050778

Vascular Loops, Sterile, Blue, Mini, 18-inch long, 2 per package

KEY SURGICAL, INC.

Surgical vessel loop
Primary Device ID50849771050778
NIH Device Record Key66950dee-0d6a-4b7d-8549-363117393a48
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberVascular Loops
Catalog NumberVL202
Company DUNS604056226
Company NameKEY SURGICAL, INC.
Device Count2
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771030843 [Previous]
GS100849771050773 [Unit of Use]
GS110849771050770 [Primary]
GS150849771050778 [Package]
Contains: 10849771050770
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDCINSTRUMENT, SURGICAL, DISPOSABLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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.

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.
00849771048190 - NA2024-10-11 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 6-inch long
00849771052562 - Key Surgical Pipe Cleaners2024-10-11 Pipe Cleaner, 1/8-inch Cotton, 50 feet
00849771050131 - NA2024-10-11 Steinmann Pins, Double diamond, threaded, .177-inch (4.5mm) diameter, 9-inch long
50849771050563 - NA2024-10-11 K-Wire Covers, Sterile, White, 2 per package
50849771050624 - NA2024-10-11 Pin Covers, Sterile, Lavender, 2 per package
50849771050655 - NA2024-10-11 Pin Covers, Sterile, Orange, 0.177-inch, 2 per package
00849771048503 - NA2024-08-30 Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.