Identity
- Trade Name
- RAYFORM Technology FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
- Model / Reference
- RF-DB-04 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16978499313042 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 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
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Custom-made organ/bone anatomy model/surgical guide kit
RAYFORM Technology by Ziyang Rayform Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Ziyang Rayform Technology Co., Ltd.
Sources (1)
- FDA UDI f6bb249a-b1f0-4b6c-9f5c-d101b7fd19a8 32 fields · synced May 31, 2026