T2 - Ankle Arthrodesis Nail, left - Stryker Trauma GmbH

Duns Number:330211587

Device Description: Ankle Arthrodesis Nail, left

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More Product Details

Catalog Number

1818-1120S

Brand Name

T2

Version/Model Number

1818-1120S

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

K051590

Product Code Details

Product Code

HSB

Product Code Name

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Record Status

Public Device Record Key

40eb7459-c705-4df7-9a2e-421477606b3e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER TRAUMA GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 365
2 A medical device with a moderate to high risk that requires special controls. 2874