PLS - SINTEA PLUSTEK SRL

Duns Number:544150399

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More Product Details

Catalog Number

-

Brand Name

PLS

Version/Model Number

 PLS-48CC3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140787

Product Code Details

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

40b2cc95-deb8-4e59-912c-8d31a878004f

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 16, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SINTEA PLUSTEK SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 854