NA - ACC 3550-05 ISTIM IN LN PERC EXTN - MEDTRONIC, INC.

Duns Number:796986144

Device Description: ACC 3550-05 ISTIM IN LN PERC EXTN

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

3550-05

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

P970004

Product Code Details

Product Code

EZW

Product Code Name

Stimulator, electrical, implantable, for incontinence

Device Record Status

Public Device Record Key

e2c25661-976d-4aa3-b1fb-cd670c11d435

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2014

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