Identity
- Trade Name
- DuraBurr FDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Burr 5.5 Spherical Blade -12,SN_5 FDA UDI
- Model / Reference
- 800300200 FDA UDI
- Description
- Burr 5.5 Spherical Blade -12,SN_5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970399639843 FDA UDI
- FDA Product Code
- HTT FDA UDI
- GMDN Term
- Arthroscopic shaver system blade, single-use 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Arthroscopic shaver system blade, single-use
DuraBurr by Hangzhou Rejoin Mastin Medical Device 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
- Hangzhou Rejoin Mastin Medical Device Co., Ltd.
Sources (1)
- FDA UDI bfae9bae-8375-49b6-ad89-09df81c9d296 33 fields · synced Jun 6, 2026