TECHDEVICE CORPORATION

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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

Wire, Guide, Catheter (DQX) (10)

Premarket Exempt

Clear

Mermaid Medical® Guidewire - 00850758007000 Catalog Number : G60135090

Device Description : Mermaid Medical® Guidewire .035” x 90 cm, 7.5 cm (Straight Tip)

Device Class :

Duns Number: 088189175

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Mermaid Medical® Guidewire - 00850758007017 Catalog Number : G60235090

Device Description : Mermaid Medical® Guidewire .035” x 90 cm, 3.5 cm (Straight Tip)

Device Class :

Duns Number: 088189175

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Mermaid Medical® Guidewire - 00850758007024 Catalog Number : G60335090

Device Description : Mermaid Medical® Guidewire .035” x 90 cm, 7.5 cm Tip (3mm “J”)

Device Class :

Duns Number: 088189175

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Mermaid Medical® Guidewire - 00850758007031 Catalog Number : G60135150

Device Description : Mermaid Medical® Guidewire .035” x 150 cm, 7.5 cm (Straight Tip)

Device Class :

Duns Number: 088189175

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Mermaid Medical® Guidewire - 00850758007048 Catalog Number : G60235150

Device Description : Mermaid Medical® Guidewire .035” x 150 cm, 3.5 cm (Straight Tip)

Device Class :

Duns Number: 088189175

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Mermaid Medical® Guidewire - 00850758007055 Catalog Number : G60135180

Device Description : Mermaid Medical® Guidewire .035” x 180 cm, 7.5 cm (Straight Tip)

Device Class :

Duns Number: 088189175

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Mermaid Medical® Guidewire - 00850758007062 Catalog Number : G60235180

Device Description : Mermaid Medical® Guidewire .035” x 180 cm, 3.5 cm (Straight Tip)

Device Class :

Duns Number: 088189175

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Mermaid Medical® Guidewire - 00850758007079 Catalog Number : G60135260

Device Description : Mermaid Medical® Guidewire .035” x 260 cm, 7.5 cm (Straight Tip)

Device Class :

Duns Number: 088189175

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Mermaid Medical® Guidewire - 00850758007086 Catalog Number : G60235260

Device Description : Mermaid Medical® Guidewire .035” x 260 cm, 3.5 cm (Straight Tip)

Device Class :

Duns Number: 088189175

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

ReShape Medical™ Guidewire - 00850758007109 Catalog Number : RSM300

Device Description : ReShape Medical™ Guidewire .035” x 260 cm, 13 cm (Straight Tip)

Device Class : 2

Duns Number: 088189175

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

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