KILTEX PROBE COVER
KILTEX CORP.
KILTEX CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1527493 | 1527493 | KILTEX CORP. | 1 | N | 2026-01-01 | 2064 KILLIAN ROAD Akron OH US 44312 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 73189 | 1929535324 | K961029 | KILTEX PROBE COVER | IYO | 1996-07-25 |
| 73189 | 1586599869 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYO | 1 | 1996-07-25 |
PMN#
GUDID#
Kiltex Corporation - A non-sterile sheath (2.0cm x 20cm) intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 100 per bag.
2016-09-13
Kiltex Corporation - A non-sterile sheath 2.0cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 500 per bag.
2016-09-13
Kiltex Corporation - A non-sterile sheath 2.6cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 100 per bag.
2016-09-13
Kiltex Corporation - A non-sterile sheath 2.6cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 500 per bag.
2016-09-13
Kiltex Corporation - A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 100 per bag.
2016-09-13
Kiltex Corporation - A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 144 per bag.
2016-09-13
Kiltex Corpoartion - A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 500 per bag.
2016-09-13
Kiltex Corporation - A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 720 per bag.
2016-09-13