VL201

GUDID 10849771050541

Vascular Loops, Sterile, Red, Mini, 2 per package

KEY SURGICAL, INC.

Surgical vessel loop
Primary Device ID10849771050541
NIH Device Record Key0d51aa98-4358-4a5d-80c3-b6e38eea8e16
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberVascular Loops
Catalog NumberVL201
Company DUNS604056226
Company NameKEY SURGICAL, INC.
Device Count1
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
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

Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch
Device Size Text, specify0
Length18 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100849771030836 [Previous]
GS100849771050544 [Primary]
GS110849771050541 [Package]
Contains: 00849771050544
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 Date2024-03-19
Device Publish Date2024-03-11

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

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