SURGITOOLS PTY. LTD.

Address:Room 426, Building 1, No.255 Shuangbang Road, Xujing Town,Qingpu District Shanghai,CN

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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

Culdoscope (And Accessories) (HEW) (6)

Premarket Exempt

Clear

ColpoWave Balloon - 09351599000119 Catalog Number :

Device Description : ColpoWave Balloon blister pack containing one sterile unit

Device Class : 2

Duns Number: 745798822

Premarket Exempt : No

Product Code : HEW

Prescription Use : Yes

Device Count : 1

ColpoWave Balloon - 09351599000126 Catalog Number :

Device Description : ColpoWave Balloon box containing 6 sterile units

Device Class : 2

Duns Number: 745798822

Premarket Exempt : No

Product Code : HEW

Prescription Use : Yes

Device Count : 1

CerviGrip Uterine Manipulator - 09351599000218 Catalog Number :

Device Description : CerviGrip Uterine Manipulator blister pack containing 1 sterile unit

Device Class : 2

Duns Number: 745798822

Premarket Exempt : No

Product Code : HEW

Prescription Use : Yes

Device Count : 1

CerviGrip Uterine Manipulator - 09351599000225 Catalog Number :

Device Description : CerviGrip Uterine Manipulator box containing 6 sterile units

Device Class : 2

Duns Number: 745798822

Premarket Exempt : No

Product Code : HEW

Prescription Use : Yes

Device Count : 1

ColpoWave Colpotomizer - 09351599000317 Catalog Number :

Device Description : ColpoWave Colpotomizer blister pack containing 1 sterile unit

Device Class : 2

Duns Number: 745798822

Premarket Exempt : No

Product Code : HEW

Prescription Use : Yes

Device Count : 1

ColpoWave Colpotomizer - 09351599000324 Catalog Number :

Device Description : ColpoWave Colpotomizer box containing 6 sterile units

Device Class : 2

Duns Number: 745798822

Premarket Exempt : No

Product Code : HEW

Prescription Use : Yes

Device Count : 1

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