NA - Tunneling Tool, 12" - ADVANCED NEUROMODULATION SYSTEMS, INC.

Duns Number:021675699

Device Description: Tunneling Tool, 12"

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More Product Details

Catalog Number

1112

Brand Name

NA

Version/Model Number

1112

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

LGW

Product Code Name

STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Record Status

Public Device Record Key

1d2277e7-138f-49e5-b2e5-e59509a8c358

Public Version Date

February 10, 2022

Public Version Number

3

DI Record Publish Date

November 12, 2014

Additional Identifiers

Package DI Number

15414734400104

Quantity per Package

5

Contains DI Package

05414734400107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ADVANCED NEUROMODULATION SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1
3 A medical device with high risk that requires premarket approval 40