LTJ - LTJ Solid Screwdriver Bit - AzurMeds Inc.

Duns Number:117700483

Device Description: LTJ Solid Screwdriver Bit

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More Product Details

Catalog Number

-

Brand Name

LTJ

Version/Model Number

81004162611

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

-

Prescription Use (Rx)

-

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

HXX

Product Code Name

Screwdriver

Device Record Status

Public Device Record Key

7c4c4b12-c022-4299-a6e1-e4d766322ef9

Public Version Date

November 05, 2020

Public Version Number

1

DI Record Publish Date

October 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AZURMEDS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 42