Beta Syringe Shield, 20 cc - Plastic and Lead Syringe Shield for Beta Emitters - CAPINTEC, INC.

Duns Number:047684501

Device Description: Plastic and Lead Syringe Shield for Beta Emitters

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More Product Details

Catalog Number

007-958

Brand Name

Beta Syringe Shield, 20 cc

Version/Model Number

007-958

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

bdad802d-e4d9-4aec-84bd-12e401a34438

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