Tungsten Vial Shield - Tungsten Vial Shield - CAPINTEC, INC.

Duns Number:047684501

Device Description: Tungsten Vial Shield

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More Product Details

Catalog Number

053-807

Brand Name

Tungsten Vial Shield

Version/Model Number

053-807

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

IWW

Product Code Name

Shield, Vial

Device Record Status

Public Device Record Key

418618e6-3d4e-4624-9057-5fc4026cb626

Public Version Date

July 19, 2022

Public Version Number

1

DI Record Publish Date

July 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAPINTEC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81
2 A medical device with a moderate to high risk that requires special controls. 17