INTRA-KNOT™ QUICK LOAD®

GUDID 10850200006282

INTRA-KNOT™ QUICK LOAD® Base Package Type - Pouch / Each

LSI Solutions, Inc.

Suture clasp, non-bioabsorbable
Primary Device ID10850200006282
NIH Device Record Key35194fe6-11af-44d9-b7af-5182acffa324
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTRA-KNOT™ QUICK LOAD®
Version Model Number032040
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
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850200006285 [Primary]
GS110850200006282 [Package]
Contains: 00850200006285
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

[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

Ethylene Oxide


[10850200006282]

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.

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10850200006497 - SEW-EASY®2024-10-29 SEW-EASY® COMBO KIT, 5mm
10850200006503 - SEW-EASY®2024-10-29 SEW-EASY® COMBO KIT, 3.5mm
10850200006510 - SEW-EASY®2024-10-29 SEW-EASY® DEVICE KIT, 5mm
10850200006527 - SEW-EASY®2024-10-29 SEW-EASY® DEVICE KIT, 3.5mm
00850012846253 - multiSTATION™2024-10-07 DOC-X 15™ EXTENDER
00850012846352 - multiSTATION™2024-10-07 DOC-X 25™ EXTENDER
00850012846369 - multiSTATION™2024-10-07 DOC-X 45™ EXTENDER

Trademark Results [INTRA-KNOT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTRA-KNOT
INTRA-KNOT
86367869 4801024 Live/Registered
LSI Solutions, Inc.
2014-08-15

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