11Ga Cannula; Matched Bevel Tip Stylet - VP BONE ACCESS VPT11B 11GA BEVEL - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: VP BONE ACCESS VPT11B 11GA BEVEL

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More Product Details

Catalog Number

-

Brand Name

11Ga Cannula; Matched Bevel Tip Stylet

Version/Model Number

VPT11B

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

8566457e-4bfa-412a-b4c9-060e7bbee5c7

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC SOFAMOR DANEK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13352
2 A medical device with a moderate to high risk that requires special controls. 26085
3 A medical device with high risk that requires premarket approval 190
U Unclassified 75