Rospital Productos Medicos - Syringe 60cc Catheter Tip, LUER LOCK, each. - ATLAS MEDICAL PRODUCTS LLC

Duns Number:013112308

Device Description: Syringe 60cc Catheter Tip, LUER LOCK, each.

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More Product Details

Catalog Number

SYCT60

Brand Name

Rospital Productos Medicos

Version/Model Number

SYCT60

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"

Yes

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

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

88548ab6-26b4-4aa6-a7e6-d5c9d6e34a9b

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Additional Identifiers

Package DI Number

10812460020071

Quantity per Package

45

Contains DI Package

00812460020074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER

"ATLAS MEDICAL PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 7