Atoll - Insertion/Final Torque Wrench w/ AO quick couple - SEASPINE ORTHOPEDICS CORPORATION

Duns Number:079840876

Device Description: Insertion/Final Torque Wrench w/ AO quick couple

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


More Product Details

Catalog Number

16-40-1202

Brand Name

Atoll

Version/Model Number

16-40-1202

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

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

HXC

Product Code Name

WRENCH

Device Record Status

Public Device Record Key

8e49dc18-e7a5-4589-acdc-a31b02b953c4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEASPINE ORTHOPEDICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5602
2 A medical device with a moderate to high risk that requires special controls. 14020
U Unclassified 21