Med Michigan Holdings, LLC

Address:2140 Oak Industrial Drive NE,Grand Rapids,MI,49505,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

Accessory Equipment, Cardiopulmonary Bypass (KRI) (5) Carrier, Ligature (GEJ) (4) Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (1)

Premarket Exempt

No Yes

Clear

Surge Cardiovascular - 00817278010002 Catalog Number : SUT-010

Device Description : Curved Suture Guide, Single Pack

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010019 Catalog Number : SUT-013

Device Description : Curved Suture Guide, 3-Pack

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010026 Catalog Number : 213-013

Device Description : Curved Suture Guide, 3 Pack

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010033 Catalog Number : 213-010

Device Description : Suture Guide, Single Pack

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010118 Catalog Number : 213-002

Device Description : Tubing Organizer, 8-Hole

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010125 Catalog Number : 213-004

Device Description : 8-Hole Tubing Organizer with Clips

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010156 Catalog Number : 215-015

Device Description : Myocardial temperature probe, 15mm needle

Device Class : 1

Duns Number: 097462979

Premarket Exempt : No

Product Code : KRI

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010163 Catalog Number : 215-030

Device Description : Myocardial temperature probe, 30mm needle

Device Class : 1

Duns Number: 097462979

Premarket Exempt : No

Product Code : KRI

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010170 Catalog Number : 215-044

Device Description : Myocardial temperature probe, 44mm needle

Device Class : 1

Duns Number: 097462979

Premarket Exempt : No

Product Code : KRI

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010224 Catalog Number : ACIP

Device Description : Adult Cardiac Insulation Pad

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

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