MD Vue Discectomy - Implant Tamp - PRECISION SPINE, INC.

Duns Number:079398589

Device Description: Implant Tamp

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More Product Details

Catalog Number

60-IT-9001

Brand Name

MD Vue Discectomy

Version/Model Number

60-IT-9001

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

HXG

Product Code Name

Tamp

Device Record Status

Public Device Record Key

89602c28-18b0-4457-9eec-702f00f1e306

Public Version Date

April 04, 2019

Public Version Number

1

DI Record Publish Date

March 27, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRECISION SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1423
2 A medical device with a moderate to high risk that requires special controls. 4960
U Unclassified 26