Arsenal Ankle 9 Hole Posterior Fibula Plate, L - Trilliant Surgical, LLC

Duns Number:828829072

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More Product Details

Catalog Number

-

Brand Name

Arsenal Ankle 9 Hole Posterior Fibula Plate, L

Version/Model Number

300-94-003

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

K212378

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

3b2e9b81-80fb-4248-9e9c-4c6b488b7809

Public Version Date

May 10, 2022

Public Version Number

1

DI Record Publish Date

May 02, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRILLIANT SURGICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 345
2 A medical device with a moderate to high risk that requires special controls. 933