PET SHIPPING SYSTEM - Shipping System, PET, Triple Dose for three - BIODEX MEDICAL SYSTEMS, INC.

Duns Number:043833813

Device Description: Shipping System, PET, Triple Dose for three single Unit Dose Pigs.

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More Product Details

Catalog Number

001-739

Brand Name

PET SHIPPING SYSTEM

Version/Model Number

001-739

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

KPY

Product Code Name

Shield, Protective, Personnel

Device Record Status

Public Device Record Key

594babb5-7c74-4f63-9fb2-007a4b2fa4af

Public Version Date

January 15, 2019

Public Version Number

1

DI Record Publish Date

December 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIODEX MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 193
2 A medical device with a moderate to high risk that requires special controls. 52