MD Vue Lateral Access - 170mm Left Blade - PRECISION SPINE, INC.

Duns Number:079398589

Device Description: 170mm Left Blade

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More Product Details

Catalog Number

54-BL-0170

Brand Name

MD Vue Lateral Access

Version/Model Number

54-BL-0170

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

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

e9d408f6-62c9-4ff1-83d2-ca331c94bb49

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