OsteoCentric 4.0 x 22mm LOCKING BONE SCREW FASTENER ST - 4.0 x 22mm LOCKING BONE SCREW FASTENER, ST - SMV SCIENTIFIC LLC

Duns Number:089645059

Device Description: 4.0 x 22mm LOCKING BONE SCREW FASTENER, ST

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

340-6022

Brand Name

OsteoCentric 4.0 x 22mm LOCKING BONE SCREW FASTENER ST

Version/Model Number

340-6022

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

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

28442c9d-0954-4bd4-a453-74269ae86d19

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMV SCIENTIFIC LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 60
2 A medical device with a moderate to high risk that requires special controls. 846