EPS Plating System Screw - Plate Screw Fixed Angle Locking Cortical 3.5 x - GRAMERCY EXTREMITY ORTHOPEDICS LLC

Duns Number:080068420

Device Description: Plate Screw Fixed Angle Locking Cortical 3.5 x 30mm, EPS

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More Product Details

Catalog Number

-

Brand Name

EPS Plating System Screw

Version/Model Number

11123530

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

a0a958a5-0fc6-4665-963c-cec913c187c5

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRAMERCY EXTREMITY ORTHOPEDICS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 65
2 A medical device with a moderate to high risk that requires special controls. 626