Pro-Tec Pet Syringe Shield - SYRINGE SHIELD, PRO-TEC PET, 5cc, HSW - BIODEX MEDICAL SYSTEMS, INC.

Duns Number:043833813

Device Description: SYRINGE SHIELD, PRO-TEC PET, 5cc, HSW

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More Product Details

Catalog Number

007-969

Brand Name

Pro-Tec Pet Syringe Shield

Version/Model Number

007-969

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

8f9ffddb-92c4-44ef-baaa-f9594815e71b

Public Version Date

October 24, 2019

Public Version Number

1

DI Record Publish Date

October 16, 2019

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