PASS LP - PEDICLE SCREWDRIVER FOR REMOVAL - MEDICREA INTERNATIONAL

Duns Number:383228632

Device Description: PEDICLE SCREWDRIVER FOR REMOVAL

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


More Product Details

Catalog Number

A02310150

Brand Name

PASS LP

Version/Model Number

A02310150

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)

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

HXX

Product Code Name

Screwdriver

Device Record Status

Public Device Record Key

210a0f63-5ed1-4f7d-b602-c8257d6ceeaa

Public Version Date

May 23, 2022

Public Version Number

3

DI Record Publish Date

October 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICREA INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1328
2 A medical device with a moderate to high risk that requires special controls. 3995