Syringe, 10 mL E01P3

GUDID 10628678061061

The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon.

Front Line Medical Technologies Inc.

General-purpose syringe, single-use
Primary Device ID10628678061061
NIH Device Record Keya6f97213-a079-4b62-935e-f1e688b6de58
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyringe, 10 mL
Version Model NumberE01P3
Catalog NumberE01P3
Company DUNS242512799
Company NameFront Line Medical Technologies Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS110628678061061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJNCatheter, Intravascular Occluding, Temporary

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-01
Device Publish Date2024-03-22

On-Brand Devices [Syringe, 10 mL]

16286780610023The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™
10628678061023The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™
10628678061061The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™

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