2 cc Pin-Tec Syringe Shield - 2 cc Pin-Tec Syringe Shield - CAPINTEC, INC.

Duns Number:047684501

Device Description: 2 cc Pin-Tec Syringe Shield

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More Product Details

Catalog Number

4300-0060

Brand Name

2 cc Pin-Tec Syringe Shield

Version/Model Number

4300-0060

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

6e700b50-c8c4-40c1-81ca-7ade343ce683

Public Version Date

July 09, 2019

Public Version Number

1

DI Record Publish Date

July 01, 2019

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