Identity
- Trade Name
- Tairuibosi FDA UDI
- Generic Name
- Orthotic shoe, non-customized FDA UDI
- Model / Reference
- TRB-502-L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974870090406 FDA UDI
- FDA Product Code
- KNP FDA UDI
- GMDN Term
- Orthotic shoe, non-customized FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthotic shoe, non-customized
Tairuibosi by Tianjin Tairuibosi Medical Appliance Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthotic shoe, non-customized.
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- DARCO® GentleStep™ Shoe — DARCO International, Inc. · Class I
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
- Tianjin Tairuibosi Medical Appliance Co., Ltd.
Sources (1)
- FDA UDI 257099fa-3089-4020-8fab-3e8f3bbff165 32 fields · synced Jun 8, 2026