Zavation - 30mm MEDIAL BLADE - ZAVATION LLC

Duns Number:069472800

Device Description: 30mm MEDIAL BLADE

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


More Product Details

Catalog Number

-

Brand Name

Zavation

Version/Model Number

480-1002-M-030

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

K112533

Product Code Details

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

77363982-66a4-46b4-98ea-bc3af1770b10

Public Version Date

April 23, 2021

Public Version Number

1

DI Record Publish Date

April 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZAVATION LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 375
2 A medical device with a moderate to high risk that requires special controls. 7471
U Unclassified 22