SHEATHING TECHNOLOGIES, INC.

Address:675 JARVIS DR.,MORGAN HILL,CA,95037,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

Transducer, Ultrasonic, Diagnostic (ITX) (10)

Premarket Exempt

Clear

Sheathes - 10842418100296 Catalog Number :

Device Description : Polyurethane, 1"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vagi Polyurethane, 1"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Semi-Rolled on Paper-Back, Extra-Long

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 50

Sheathes - 10842418100302 Catalog Number :

Device Description : Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Ta Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 100

Sheathes - 10842418100319 Catalog Number :

Device Description : Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Ta Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 400

Sheathes - 10842418100326 Catalog Number :

Device Description : Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Ta Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 720

Sheathes - 10842418100333 Catalog Number :

Device Description : Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Ta Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 600

Sheathes - 10842418100340 Catalog Number :

Device Description : Polyurethane, 1"D x 9"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal Polyurethane, 1"D x 9"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 50

Sheathes - 10842418100357 Catalog Number :

Device Description : Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Ta Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Individually Wrapped

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 100

Sheathes - 10842418100364 Catalog Number :

Device Description : Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover with 1 Elastic, Vag Polyurethane, 1"D x 9"L, Non-Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled, Individually Wrapped

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 60

Sheathes - 10842418100371 Catalog Number :

Device Description : Polyurethane, 1"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Polyurethane, 1"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 100

Sheathes - 10842418100388 Catalog Number :

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 400

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