Catalog Number

412-644C

Brand Name

SCOVILLE NERVE ROOT RETRACTOR

Version/Model Number

412-644C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

FGN

Product Code Name

RETRACTOR, NON-SELF-RETAINING

Public Device Record Key

e7477b0a-c2dc-4339-9a8c-3a79def80d89

Public Version Date

December 21, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-