RP Medical - Pivot Osteotome angled right short - RP Medical Inc

Duns Number:203732607

Device Description: Pivot Osteotome angled right short

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


More Product Details

Catalog Number

-

Brand Name

RP Medical

Version/Model Number

39.1960.51.01

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

-

Prescription Use (Rx)

-

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

GFI

Product Code Name

Osteotome, Manual

Device Record Status

Public Device Record Key

4bd37318-7688-4be8-9868-b7ba7324a902

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RP MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 1