KYPHON Express II Inflatable Bone Tamp - BONE TAMP KE152 15/2 EXPRESS II IBT - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: BONE TAMP KE152 15/2 EXPRESS II IBT

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More Product Details

Catalog Number

-

Brand Name

KYPHON Express II Inflatable Bone Tamp

Version/Model Number

KE152

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123771

Product Code Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

6a0cfcde-542c-4a9c-ad3d-33ac1acdebc6

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 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