FARETEC, INC.

Address:1610 W. JACKSON ST. No. 6,Painesville,OH,44077,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

Splint, Extremity, Non-Inflatable, External, Non-Sterile (NOC) (6) Splint, Traction (HSP) (4)

Premarket Exempt

Yes

Clear

CT-6 Traction splint - B54111266340 Catalog Number : 1126634

Device Description : CT-6 EMS NYC leg traction splint

Device Class : 1

Duns Number: 626802540

Premarket Exempt : Yes

Product Code : HSP

Prescription Use : No

Device Count : 1

CT-7 Traction splint - B54111266360 Catalog Number : 1126636

Device Description : CT-7 Leg traction splint with orange straps and black case

Device Class : 1

Duns Number: 626802540

Premarket Exempt : Yes

Product Code : HSP

Prescription Use : No

Device Count : 1

QD Combo - B54111267160 Catalog Number : 1126716

Device Description : QD Combination leg traction splints with molded ratchet, 1 QD-4 and 1 QD-3 splints

Device Class : 1

Duns Number: 626802540

Premarket Exempt : Yes

Product Code : HSP

Prescription Use : No

Device Count : 1

QD Combo - B54111267260 Catalog Number : 1126726

Device Description : QD Combination leg splints with aluminum ratchet, 1 QD-4 and 1 QD-3 splints

Device Class : 1

Duns Number: 626802540

Premarket Exempt : Yes

Product Code : HSP

Prescription Use : No

Device Count : 1

Wire Ladder Splint - B54112113000 Catalog Number : 1211300

Device Description : Wire Ladder splint

Device Class : 1

Duns Number: 626802540

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : No

Device Count : 1

Redi Splint - B54112113050 Catalog Number : 1211305

Device Description : Redi Universal splint, extra small , black, flat. Moldable first aid splint

Device Class : 1

Duns Number: 626802540

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : No

Device Count : 1

Redi Splint - B54112113060 Catalog Number : 1211306

Device Description : Redi Splint, Small, black, Flat. Moldable first aid splint

Device Class : 1

Duns Number: 626802540

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : No

Device Count : 1

Redi Splint - B54112113071 Catalog Number : 1211307

Device Description : Redi Splint 2, Small, Black, Box of 4

Device Class : 1

Duns Number: 626802540

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : No

Device Count : 1

Redi Splint - B54112113081 Catalog Number : 1211308

Device Description : Redi Splint, Large, Black, Box of 4

Device Class : 1

Duns Number: 626802540

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : No

Device Count : 1

Redi Splint - B54112113090 Catalog Number : 1211309

Device Description : Redi Splint, Large, black, flat. Moldable first aid splint

Device Class : 1

Duns Number: 626802540

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : No

Device Count : 1

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