FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Kiltex Corporation
DI: 00859297006079
·
Model: 3.5UltrasoundProbeCover(720)
·
Kiltex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kiltex Corporation
- Primary DI
- 00859297006079
- Version / Model
- 3.5UltrasoundProbeCover(720)
- Company Name
- Kiltex Corporation
- Labeler DUNS
- 024475421
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 5
- Public Version Date
- 2023-09-25
- Public Version Status
- Update
- Public Device Record Key
- de163901-9bda-4e8e-8e43-b233843e0d9d
- Distribution End Date
- 2023-09-24
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60609 | Body-orifice ultrasound imaging transducer cover, basic, non-sterile | A non-sterile sheath 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859297006079 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K961029 | 000 |