INTRA-KNOT™ QUICK LOAD® - INTRA-KNOT™ QUICK LOAD®Base Package Type - Pouch - LSI Solutions, Inc.

Duns Number:603420183

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

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More Product Details

Catalog Number

032040

Brand Name

INTRA-KNOT™ QUICK LOAD®

Version/Model Number

032040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100593,K100593

Product Code Details

Product Code

HCF

Product Code Name

Instrument, Ligature Passing And Knot Tying

Device Record Status

Public Device Record Key

35194fe6-11af-44d9-b7af-5182acffa324

Public Version Date

July 16, 2020

Public Version Number

4

DI Record Publish Date

December 04, 2015

Additional Identifiers

Package DI Number

10850200006282

Quantity per Package

12

Contains DI Package

00850200006285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box / Inner Pack

"LSI SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 56
2 A medical device with a moderate to high risk that requires special controls. 31