LZI Oxycodone 100 Level 2 Control - 5mL/bottleConcentration: 125 ng/mL of Oxycodone - LIN-ZHI INTERNATIONAL, INC.

Duns Number:840839190

Device Description: 5mL/bottleConcentration: 125 ng/mL of Oxycodone

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More Product Details

Catalog Number

0618

Brand Name

LZI Oxycodone 100 Level 2 Control

Version/Model Number

0618

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

-

Product Code Details

Product Code

LAS

Product Code Name

Drug Specific Control Materials

Device Record Status

Public Device Record Key

7f67f195-5432-4302-8d35-c9518edb536f

Public Version Date

August 26, 2021

Public Version Number

1

DI Record Publish Date

August 18, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIN-ZHI INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 104
2 A medical device with a moderate to high risk that requires special controls. 258
U Unclassified 2