HU-FRIEDY - DE5 Mallery 3ML Explorer - HU-FRIEDY MFG. CO., LLC

Duns Number:005085972

Device Description: DE5 Mallery 3ML Explorer

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More Product Details

Catalog Number

ZM0505

Brand Name

HU-FRIEDY

Version/Model Number

ZM0505

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

EKB

Product Code Name

EXPLORER, OPERATIVE

Device Record Status

Public Device Record Key

1091225e-d125-4c32-abb2-6669ea80ee01

Public Version Date

November 20, 2020

Public Version Number

1

DI Record Publish Date

November 12, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HU-FRIEDY MFG. CO., LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7436
2 A medical device with a moderate to high risk that requires special controls. 238