TLS - 4mm Flat Drain with Side Holes, Sterile - Stryker Leibinger GmbH & Co. KG

Duns Number:316153956

Device Description: 4mm Flat Drain with Side Holes, Sterile

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More Product Details

Catalog Number

6660

Brand Name

TLS

Version/Model Number

6660

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

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

K833586,K833586

Product Code Details

Product Code

GCY

Product Code Name

APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Device Record Status

Public Device Record Key

3d13343b-4a67-45f7-a1ac-264f6f6099f4

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

August 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER LEIBINGER GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 777
2 A medical device with a moderate to high risk that requires special controls. 2520