Identity
- Trade Name
- Kiltex Corporation FDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, image-enhancement FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 2.0UltrasoundProbeCover(100) FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859297006000 FDA UDI
- 510(k) Number
- K961029 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Body-orifice ultrasound imaging transducer cover, image-enhancement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Body-orifice ultrasound imaging transducer cover, image-enhancement
Kiltex Corporation by Kiltex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K961029 also covers:
- Kiltex Corpoartion — Kiltex Corp.
- Kiltex Corporation — Kiltex Corp.
- Kiltex Corporation — Kiltex Corp.
- Kiltex Corporation — Kiltex Corp.
- Kiltex Corporation — Kiltex Corp.
- Kiltex Corporation — Kiltex Corp.
- Kiltex Corporation — Kiltex Corp.
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kiltex Corp.
Sources (1)
- FDA UDI d41329a5-75b2-4388-b106-319f7f790faf 35 fields · synced May 30, 2026