MERCURY - POLYAXIAL SCREWDRIVER SHAFT W/ ROTATING SLEEVE - SPINAL ELEMENTS, INC.

Duns Number:610712213

Device Description: POLYAXIAL SCREWDRIVER SHAFT W/ ROTATING SLEEVE

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


More Product Details

Catalog Number

-

Brand Name

MERCURY

Version/Model Number

62150-009

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

93ca371a-1b3d-49dc-9c15-a005a3fd045e

Public Version Date

February 22, 2021

Public Version Number

2

DI Record Publish Date

October 22, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINAL ELEMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4289
2 A medical device with a moderate to high risk that requires special controls. 2600