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“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) FDA UDI
- Generic Name
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
- Device Name
- Ball Tip Sounder FDA UDI
- Model / Reference
- 406-0401 FDA UDI
- Description
- Ball Tip Sounder FDA UDI
Identifiers
- Catalog Number
- 406-0401 FDA UDI
- Primary DI / UDI-DI
- 04719878786928 FDA UDI
- FDA Product Code
- HXB FDA UDI
- GMDN Term
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Abdominal/ENT/orthopaedic surgical probe, reusable
“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) by Paonan Biotech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Abdominal/ENT/orthopaedic surgical probe, reusable.
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- General Instruments — ALPHATEC SPINE, INC. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, 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
- Paonan Biotech Co., Ltd.
Sources (1)
- FDA UDI 0d9f8f0f-4789-418b-a309-77e95deab228 34 fields · synced Jun 1, 2026