Medtronic Reusable Instruments - RASP EX1010924 10MM X 22MM BI-CONVEX - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: RASP EX1010924 10MM X 22MM BI-CONVEX

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More Product Details

Catalog Number

-

Brand Name

Medtronic Reusable Instruments

Version/Model Number

EX1010924

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

HTR

Product Code Name

RASP

Device Record Status

Public Device Record Key

1f36a5e2-1283-4496-9380-1106b6e3deb2

Public Version Date

October 18, 2022

Public Version Number

1

DI Record Publish Date

October 10, 2022

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