TRYPTIK LA-Instruments - LAMINOPLASTY STAPLE TRAY - SpineArt SA

Duns Number:483016148

Device Description: LAMINOPLASTY STAPLE TRAY

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More Product Details

Catalog Number

TRY-BX 90 02-N

Brand Name

TRYPTIK LA-Instruments

Version/Model Number

TRY-BX 90 02-N

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

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

f74a81e3-30b9-4c7a-89ac-c3ce9e6b76d1

Public Version Date

April 06, 2021

Public Version Number

1

DI Record Publish Date

March 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINEART SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 974
2 A medical device with a moderate to high risk that requires special controls. 5209