BE-ST NIM PAK Needle Trocar - Pedicle Access Kit Needle with Neural Integrity - LACEY MANUFACTURING COMPANY, LLC

Duns Number:958212029

Device Description: Pedicle Access Kit Needle with Neural Integrity Monitor

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More Product Details

Catalog Number

PK1007

Brand Name

BE-ST NIM PAK Needle Trocar

Version/Model Number

PK1007

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"

Yes

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

PDQ

Product Code Name

Neurosurgical Nerve Locator

Device Record Status

Public Device Record Key

b8fc6b79-9eb3-46cb-8a6f-fb6e38c459d1

Public Version Date

May 20, 2019

Public Version Number

1

DI Record Publish Date

May 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LACEY MANUFACTURING COMPANY, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18