KARL STORZ - TRAY, LAPAROSCOPIC INSTRUMENT SETUP TO 12 - Tecomet

Duns Number:118087931

Device Description: TRAY, LAPAROSCOPIC INSTRUMENT SETUP TO 12 CLICKLINE INSTRUMENTS

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More Product Details

Catalog Number

KSE09044

Brand Name

KARL STORZ

Version/Model Number

KSE09044

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

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

K012105

Product Code Details

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

8d04a1b7-3b31-4e0d-a8df-129458c4f98a

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

December 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TECOMET" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 133