Multiuse Screw, 3.5mm - Multiuse Screw, Ø3.5mm x L45mm - MIAMI DEVICE SOLUTIONS LLC

Duns Number:078703080

Device Description: Multiuse Screw, Ø3.5mm x L45mm

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More Product Details

Catalog Number

MDS1102M45

Brand Name

Multiuse Screw, 3.5mm

Version/Model Number

MDS1102M45

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

-

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

28e92db8-d9c5-4d39-a32d-00c3baf179e3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIAMI DEVICE SOLUTIONS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 464