TK® QUICK LOAD®

GUDID 10850200006244

TK® QUICK LOAD® Base Package Type - Pouch / Each

LSI Solutions, Inc.

Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable
Primary Device ID10850200006244
NIH Device Record Key98a6ae87-53b9-40c4-aec0-9675a0c10f92
Commercial Distribution StatusIn Commercial Distribution
Brand NameTK® QUICK LOAD®
Version Model Number030510
Company DUNS603420183
Company NameLSI Solutions, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com

Device Dimensions

Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch
Lumen/Inner Diameter0.035 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100850200006247 [Primary]
GS110850200006244 [Package]
Contains: 00850200006247
Package: Box / Inner Pack [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCFInstrument, Ligature Passing And Knot Tying

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

[10850200006244]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-12-04

Devices Manufactured by LSI Solutions, Inc.

10850012846281 - VIRTUOSEW™2024-02-22 VIRTUOSEW™ DEVICE
10850012846298 - AVR NAVIGATOR™2024-02-12 AVR NAVIGATOR™ SMALL RETRACTOR WITH DELIVERY DEVICE
10850012846304 - AVR NAVIGATOR™2024-02-12 AVR NAVIGATOR™ MEDIUM RETRACTOR WITH DELIVERY DEVICE
10850012846311 - AVR NAVIGATOR™2024-02-12 AVR NAVIGATOR™ LARGE RETRACTOR WITH DELIVERY DEVICE
00850012846321 - miniARM® multiSTATION™ System2024-01-11 BITA RetroSterno™ Paddle
10850012846267 - AnastoPod™2023-07-31 AnastoPod™ DEVICE
10850012846007 - PNEUMOSTOP®2022-11-14 PNEUMOSTOP® DEVICE
10850012846014 - PNEUMOSTOP®2022-11-14 PNEUMOSTOP® PLUS DEVICE
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.