SHERPA NX BALANCED - CATHETER SB7RBU40SH SB 7F 100CM RB40 - MEDTRONIC, INC.

Duns Number:006261481

Device Description: CATHETER SB7RBU40SH SB 7F 100CM RB40

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More Product Details

Catalog Number

-

Brand Name

SHERPA NX BALANCED

Version/Model Number

SB7RBU40SH

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 03, 2017

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

K051846

Product Code Details

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Device Record Status

Public Device Record Key

97fd1be6-2a84-4da2-a4c2-434dd7e8c240

Public Version Date

December 22, 2021

Public Version Number

7

DI Record Publish Date

May 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 20495
3 A medical device with high risk that requires premarket approval 3601