Syringe, 10 mL - The Syringe, 10 mL is a component of the - Front Line Medical Technologies Inc.

Duns Number:242512799

Device Description: The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS

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More Product Details

Catalog Number

E01P3

Brand Name

Syringe, 10 mL

Version/Model Number

E01P3

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

K201652

Product Code Details

Product Code

MJN

Product Code Name

Catheter, Intravascular Occluding, Temporary

Device Record Status

Public Device Record Key

4d2e4516-796e-435e-9a7f-10a53ece5bfa

Public Version Date

February 17, 2022

Public Version Number

1

DI Record Publish Date

February 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FRONT LINE MEDICAL TECHNOLOGIES INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2