VL214

GUDID 50849771050846

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

KEY SURGICAL, INC.

Surgical vessel loop
Primary Device ID50849771050846
NIH Device Record Key0ca75393-502b-41aa-a5e0-d92ad1e40f98
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberVascular Loops
Catalog NumberVL214
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
GS100849771030911 [Previous]
GS100849771050841 [Unit of Use]
GS110849771050848 [Primary]
GS150849771050846 [Package]
Contains: 10849771050848
Package: Box [10 Units]
In Commercial Distribution

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 Date2024-08-09
Device Publish Date2024-08-01

Devices Manufactured by KEY SURGICAL, INC.

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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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