TPS - TPS Micro Sag Saw Irr. Clip - STRYKER CORPORATION

Duns Number:196548481

Device Description: TPS Micro Sag Saw Irr. Clip

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More Product Details

Catalog Number

5100-034-500

Brand Name

TPS

Version/Model Number

5100034500

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

-

Product Code Details

Product Code

EIA

Product Code Name

UNIT, OPERATIVE DENTAL

Device Record Status

Public Device Record Key

f09eed70-637e-4b74-a27e-921ec30a12e1

Public Version Date

January 20, 2020

Public Version Number

6

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60