Precision®, NA - Holster - BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Duns Number:824951958

Device Description: Holster

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More Product Details

Catalog Number

SC-6200

Brand Name

Precision®, NA

Version/Model Number

SC-6200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

P030017

Product Code Details

Product Code

LGW

Product Code Name

STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Record Status

Public Device Record Key

0d05f000-1739-42aa-a53c-e72c7a0110c3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BOSTON SCIENTIFIC NEUROMODULATION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 248
3 A medical device with high risk that requires premarket approval 442