Identity
- Trade Name
- SiteRite FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- BD SiteRite 9 Ultrasound System Probe Holder FDA UDI
- Model / Reference
- 9770816 FDA UDI
- Description
- BD SiteRite 9 Ultrasound System Probe Holder FDA UDI
Identifiers
- Catalog Number
- 9770816 FDA UDI
- Primary DI / UDI-DI
- 00801741234347 FDA UDI
- 510(k) Number
- K231283 FDA UDI
- FDA Product Code
- IYO FDA UDIITX FDA UDILLZ FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose ultrasound imaging system
SiteRite by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231283 also covers:
- BD SiteRite 9 Ultrasound System — Bard Access Systems, Inc.
- BD SiteRite 9 Ultrasound System — Bard Access Systems, Inc.
- BD SiteRite 9 Ultrasound System — Bard Access Systems, Inc.
- BD SiteRite 9 Ultrasound System — Bard Access Systems, Inc.
- BD SiteRite 9 Ultrasound System — Bard Access Systems, Inc.
- BD SiteRite 9 Ultrasound System — Bard Access Systems, Inc.
- BD SiteRite 9 Ultrasound System — Bard Access Systems, Inc.
- SiteRite — Bard Access Systems, Inc.
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
- Bard Access Systems, Inc.
Sources (1)
- FDA UDI 3c825106-67e8-4966-82b9-8bcf3c223908 37 fields · synced Jun 9, 2026