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

Radiology-Diagnostic Kit (OIP) (5) Biopsy Needle Guide Kit (OIJ) (3) Transducer, Ultrasonic, Diagnostic (ITX) (2)

Premarket Exempt

Clear

Sheathes - 10842418104447 Catalog Number :

Device Description : Latex-Free, 6"W x 96"L (15.2cm x 244cm), Sterile, Ultrasound Needle Guide Kit wi Latex-Free, 6"W x 96"L (15.2cm x 244cm), Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 Elastics, Three 18g Needle Guide Sets (1 Each of 1.5, 2.5, & 3.5cm), Tilt-Out Style

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : OIJ

Prescription Use : No

Device Count : 10

Sheathes - 10842418104454 Catalog Number :

Device Description : Latex-Free, 6"W x 96"L (15.2cm x 244cm), Sterile, Ultrasound Needle Guide Kit wi Latex-Free, 6"W x 96"L (15.2cm x 244cm), Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 Elastics, Three 21g Needle Guide Sets (1 Each of 1.0, 1.5, & 2.0cm), Tilt-Out Style

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : OIJ

Prescription Use : No

Device Count : 10

Sheathes - 10842418104461 Catalog Number :

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : OIJ

Prescription Use : No

Device Count : 10

Sheathes3D - 10842418104478 Catalog Number :

Device Description : Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 24"L, Exte Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 24"L, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 25

Vital Care Industries - 10842418104485 Catalog Number :

Device Description : Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Ultrasound Probe Cov Polyurethane, 7/8"D Tapered to 2.9"W 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 : 75

Sheathes3D - 10842418104492 Catalog Number :

Device Description : 5-357-IL726 Sheathes3D Seamless Viral Barrier, Latex-Free, 1" x 3.2" Face to 6"W 5-357-IL726 Sheathes3D Seamless Viral Barrier, Latex-Free, 1" x 3.2" Face to 6"W x 72"L & 5.5"W x 12"L Ultrasound Probe Covers, Sterile, with 20ml Sterile Gel & 2 Elastics, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : OIP

Prescription Use : No

Device Count : 10

Sheathes - 10842418104508 Catalog Number :

Device Description : 5-357-486, Bag, Sheathes, Polyurethane, 6"W x 48"L Ultrasound Probe Cover with a 5-357-486, Bag, Sheathes, Polyurethane, 6"W x 48"L Ultrasound Probe Cover with a 5.5"W x 12"L Ultrasound Probe Cover, Sterile, with 20ml Sterile Gel & 2 Elastics, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : OIP

Prescription Use : No

Device Count : 10

Sheathes - 10842418104515 Catalog Number :

Device Description : 5-357-586, Bag, Sheathes, Polyurethane, 6"W x 58"L Ultrasound Probe Cover with a 5-357-586, Bag, Sheathes, Polyurethane, 6"W x 58"L Ultrasound Probe Cover with a 5.5"W x 12"L Ultrasound Probe Cover, Sterile, with 20ml Sterile Gel & 2 Elastics, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : OIP

Prescription Use : No

Device Count : 10

Sheathes - 10842418104522 Catalog Number :

Device Description : 5-357-726, Bag, Sheathes, Polyurethane, 6"W x 72"L Ultrasound Probe Cover with a 5-357-726, Bag, Sheathes, Polyurethane, 6"W x 72"L Ultrasound Probe Cover with a 5.5"W x 12"L Ultrasound Probe Cover, Sterile, with 20ml Sterile Gel & 2 Elastics, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : OIP

Prescription Use : No

Device Count : 10

Sheathes3D - 10842418104539 Catalog Number :

Device Description : 5-1245-IH486, Bag, Polyurethane, 1"x 3" Face to 6"W x 48"L Probe Cover with a 4. 5-1245-IH486, Bag, Polyurethane, 1"x 3" Face to 6"W x 48"L Probe Cover with a 4.5"W x 12"L Ultrasound Probe Cover, Sterile, with 20ml Sterile Gel & 2 Elastics, Rolled

Device Class :

Duns Number: 806806220

Premarket Exempt : No

Product Code : OIP

Prescription Use : No

Device Count : 10

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