C2DX, INC.

C2DX, INC.

Address:555 E Eliza St,Schoolcraft,MI,49087,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

Monitor, Pressure, Intracompartmental (LXC) (6) Pack, Hot Or Cold, Water Circulating (ILO) (4)

Premarket Exempt

No Yes

Clear

STIC Intracompartmental Pressure Monitor - 00850007350055 Catalog Number :

Device Description : The STIC Intracompartmental Pressure Monitor system is intended to measure compa The STIC Intracompartmental Pressure Monitor system is intended to measure compartmental pressure to aid in diagnosis of compartment syndrome.

Device Class : U

Duns Number: 116981210

Premarket Exempt : No

Product Code : LXC

Prescription Use : Yes

Device Count : 1

T/Pump - 00850007350130 Catalog Number :

Device Description : T/pump Professional

Device Class : 2

Duns Number: 116981210

Premarket Exempt : No

Product Code : ILO

Prescription Use : Yes

Device Count : 1

T/Pump - 00850007350147 Catalog Number :

Device Description : T/pump Professional

Device Class : 2

Duns Number: 116981210

Premarket Exempt : No

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Indwelling Slit Catheter - 10850007350007 Catalog Number :

Device Description : Indwell Slit Catheter Set (12/pkg). Each set includes slit catheter, breakaway n Indwell Slit Catheter Set (12/pkg). Each set includes slit catheter, breakaway needle and extension tubing.

Device Class : U

Duns Number: 116981210

Premarket Exempt : No

Product Code : LXC

Prescription Use : Yes

Device Count : 12

Quick Pressure Monitor Set - 10850007350014 Catalog Number :

Device Description : 6/pkg. Each set includes pre-filled syringe, diaphragm chamber, and side-ported needle

Device Class : U

Duns Number: 116981210

Premarket Exempt : No

Product Code : LXC

Prescription Use : Yes

Device Count : 6

Quick Pressure Monitor Set (Japan) - 10850007350021 Catalog Number :

Device Description : Quick Pressure Monitor set (6/pk Chamber and side ported needle)

Device Class : U

Duns Number: 116981210

Premarket Exempt : No

Product Code : LXC

Prescription Use : Yes

Device Count : 6

Side Ported Needle - 10850007350038 Catalog Number :

Device Description : Side Ported Needle (12/pk)

Device Class : U

Duns Number: 116981210

Premarket Exempt : No

Product Code : LXC

Prescription Use : Yes

Device Count : 12

Syringe, 3cc - 10850007350045 Catalog Number :

Device Description : Syringe, 3cc, sodium chloride injection USP 0.9% (10/pkg)

Device Class :

Duns Number: 116981210

Premarket Exempt : No

Product Code : LXC

Prescription Use : Yes

Device Count : 10

Mul-T-Pad - 10850007350076 Catalog Number :

Device Description : Temperature Therapy Pad

Device Class : 2

Duns Number: 116981210

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

Mul-T-Pad - 10850007350083 Catalog Number :

Device Description : Temperature Therapy Pad

Device Class : 2

Duns Number: 116981210

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 10

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