RNA - QC 463 Multi-Level Carton - Rna Medical Division

Duns Number:101187037

Device Description: QC 463 Multi-Level Carton

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More Product Details

Catalog Number

QC 463

Brand Name

RNA

Version/Model Number

QC 463 Multi-Level

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)

-

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

61aeb7fa-5f04-4946-baf9-924f1ac5d6ac

Public Version Date

November 06, 2019

Public Version Number

1

DI Record Publish Date

October 29, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RNA MEDICAL DIVISION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2