Capintec Syringe Shield - 511 Dose Drawing Syringe Shield, 10 cc - CAPINTEC, INC.

Duns Number:047684501

Device Description: 511 Dose Drawing Syringe Shield, 10 cc

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More Product Details

Catalog Number

0665-2011

Brand Name

Capintec Syringe Shield

Version/Model Number

511 Dose Drawing Syringe Shield, 10 cc

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

4b018a69-1623-4e27-bb93-71a3f91b66a0

Public Version Date

December 31, 2018

Public Version Number

1

DI Record Publish Date

November 28, 2018

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