PRO-TEC PIG - Pig, Pro-Tec, 3/6cc, White - BIODEX MEDICAL SYSTEMS, INC.

Duns Number:043833813

Device Description: Pig, Pro-Tec, 3/6cc, White

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More Product Details

Catalog Number

001-281

Brand Name

PRO-TEC PIG

Version/Model Number

001-281

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

IWR

Product Code Name

Holder, Syringe, Lead

Device Record Status

Public Device Record Key

d2b6093b-dc44-427f-94d9-85e171958351

Public Version Date

April 22, 2019

Public Version Number

1

DI Record Publish Date

April 12, 2019

Additional Identifiers

Package DI Number

10718175000820

Quantity per Package

6

Contains DI Package

00718175000823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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