K-wire Ø1.3 x L100mm - K-wire Ø1.3 x L100mm - MIAMI DEVICE SOLUTIONS LLC

Duns Number:078703080

Device Description: K-wire Ø1.3 x L100mm

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More Product Details

Catalog Number

MDS001013100R

Brand Name

K-wire Ø1.3 x L100mm

Version/Model Number

MDS001013100R

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

bc506660-a9e1-49f1-987a-d7a0ce5b24bb

Public Version Date

January 17, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2018

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