Nalu Medical, Inc. - Tearaway introducer assembly (10 cm sheath) - NALU MEDICAL, INC.

Duns Number:067140761

Device Description: Tearaway introducer assembly (10 cm sheath)

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More Product Details

Catalog Number

23003-045

Brand Name

Nalu Medical, Inc.

Version/Model Number

23003-045

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

GZB

Product Code Name

Stimulator, Spinal-Cord, Implanted (Pain Relief)

Device Record Status

Public Device Record Key

af68228d-dd15-4c98-beb7-2d46658b3511

Public Version Date

October 03, 2022

Public Version Number

2

DI Record Publish Date

April 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NALU MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 270