Screwdriver Bit Torx - Screwdriver Bit T4 Torx, Single Use - Neurovention LLC

Duns Number:074912476

Device Description: Screwdriver Bit T4 Torx, Single Use

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More Product Details

Catalog Number

-

Brand Name

Screwdriver Bit Torx

Version/Model Number

333-01

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

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

HAO

Product Code Name

Instrument, Surgical, Non-Powered

Device Record Status

Public Device Record Key

33db953b-29d8-437f-a52b-7f71ada2a868

Public Version Date

June 29, 2022

Public Version Number

1

DI Record Publish Date

June 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEUROVENTION LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 7