QL Fluid Dispensing Syringe - QL Fluid Dispensing Syringe: 4mL, 100psi - ATRION MEDICAL PRODUCTS, INC.

Duns Number:047571476

Device Description: QL Fluid Dispensing Syringe: 4mL, 100psi

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More Product Details

Catalog Number

96476

Brand Name

QL Fluid Dispensing Syringe

Version/Model Number

QL® 4100

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

Yes

Prescription Use (Rx)

Yes

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

DXT

Product Code Name

Injector And Syringe, Angiographic

Device Record Status

Public Device Record Key

3ddcfda6-5a69-42aa-847a-2bdaf9d0070e

Public Version Date

January 11, 2021

Public Version Number

5

DI Record Publish Date

August 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ATRION MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 61