MEDSOURCE INTERNATIONAL LLC

Address:8600 Shelby Court, Suite 100,Chanhassen,MN,55317,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (3) Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (FOZ) (3) Instrument, Manual, Surgical, General Use (MDM) (2) Device, Transfer, Patient, Manual (FMR) (1) Tube, Tracheal (W/Wo Connector) (BTR) (1)

Premarket Exempt

No Yes

Clear

MedSource Skin Biopsy Punch - 00840155412552 Catalog Number : Not Applicable

Device Description : Skin Biopsy Punch, 1.5mm

Device Class : 1

Duns Number: 041674552

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

MedSource ET Tubes - 00840155412576 Catalog Number : Not Applicable

Device Description : ET Tube, 4.5mm Cuffed

Device Class :

Duns Number: 041674552

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

MedSource Sampling Cannula - 00840155413061 Catalog Number : Not Applicable

Device Description : 7’ Adult Nasal CO2 Sampling Cannula

Device Class :

Duns Number: 041674552

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

MedSource Sampling Cannula - 00840155413092 Catalog Number : Not Applicable

Device Description : 10’ Adult Nasal CO2 Sampling Cannula

Device Class :

Duns Number: 041674552

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

MedSource Sampling Cannula - 00840155413122 Catalog Number : Not Applicable

Device Description : 14’ Adult Nasal CO2 Sampling Cannula

Device Class :

Duns Number: 041674552

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

MedSource Skin Biopsy Punch - 00840155413153 Catalog Number : Not Applicable

Device Description : Biopsy Punch 2.00mm

Device Class : 1

Duns Number: 041674552

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

MedSource Catheters - 00840155413184 Catalog Number : Not Applicable

Device Description : TrueSafe Comfort BC IV Catheter 14G- 1.75''

Device Class :

Duns Number: 041674552

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

MedSource Catheters - 00840155413214 Catalog Number : Not Applicable

Device Description : TrueSafe Comfort BC IV Catheter 16G- 1.16"

Device Class :

Duns Number: 041674552

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

MedSource Catheters - 00840155413245 Catalog Number : Not Applicable

Device Description : TrueSafe Comfort BC IV Catheter 20G- 1"

Device Class :

Duns Number: 041674552

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

MedSource Fast Stretcher - 00840155413283 Catalog Number : Not Applicable

Device Description : Fast Stretcher

Device Class :

Duns Number: 041674552

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

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