Identity
- Trade Name
- Scanning Kit FDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- Non-sterile extension tube, (60cc) syringe and 3-way stopcock FDA UDI
- Model / Reference
- 610-224 FDA UDI
- Description
- Non-sterile extension tube, (60cc) syringe and 3-way stopcock FDA UDI
Identifiers
- Catalog Number
- 610-224 FDA UDI
- Primary DI / UDI-DI
- 10841436103623 FDA UDI
- 510(k) Number
- K895614 FDA UDI
- FDA Product Code
- IYD FDA UDI
- GMDN Term
- Body-surface ultrasound imaging transducer cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5900 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 60 Milliliter FDA UDILength — 6.37 Inch FDA UDI
Scanning Kit by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Civco Medical Instruments Co., Inc.
Sources (1)
- FDA UDI 96f66315-96ee-449e-960a-d81bad7543a1 39 fields · synced Jun 8, 2026