Dose Drawing Syringe Shield, 10/12 cc, with Replaceable Glass - Dose Drawing Syringe Shield, 10/12 cc, with - CAPINTEC, INC.

Duns Number:047684501

Device Description: Dose Drawing Syringe Shield, 10/12 cc, with Replaceable Glass

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More Product Details

Catalog Number

7-695

Brand Name

Dose Drawing Syringe Shield, 10/12 cc, with Replaceable Glass

Version/Model Number

007-695

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

588a78d1-249d-4c1e-8cd4-7e4ed5f8676c

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