Baby Gorilla/Gorilla Plating System - SILVERBACK Non-Locking Plate Screw, 5.2 x 18mm - PARAGON 28, INC.

Duns Number:042961576

Device Description: SILVERBACK Non-Locking Plate Screw, 5.2 x 18mm

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More Product Details

Catalog Number

P50-653-5218

Brand Name

Baby Gorilla/Gorilla Plating System

Version/Model Number

P50-653-5218

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K190365

Product Code Details

Product Code

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

14c828f3-ed0e-4b43-9503-bea0989eda7d

Public Version Date

October 25, 2019

Public Version Number

1

DI Record Publish Date

October 17, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARAGON 28, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1122
2 A medical device with a moderate to high risk that requires special controls. 3564