PECTUS SYSTEM - BIOMET MICROFIXATION, INC

Duns Number:046189866

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More Product Details

Catalog Number

-

Brand Name

PECTUS SYSTEM

Version/Model Number

PT-4473

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

K061384

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

a2feab09-4815-4aff-b70c-2fcdd08e2dc0

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET MICROFIXATION, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1783
2 A medical device with a moderate to high risk that requires special controls. 11874
3 A medical device with high risk that requires premarket approval 34