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Reprocessed Apollo RF Aspirating Ablator 90, Extra Large
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Reprocessed Apollo RF Aspirating Ablator 90, Extra Large FDA UDI
- Generic Name
- Arthroscopic shaver system blade, reprocessed FDA UDI
- Device Name
- Apollo RF XL90, Aspirating Ablator 90°, Extra Large FDA UDI
- Model / Reference
- AR-9821 FDA UDI
- Description
- Apollo RF XL90, Aspirating Ablator 90°, Extra Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- B390AR98211 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Arthroscopic shaver system blade, reprocessed FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Reprocessed Apollo RF Aspirating Ablator 90, Extra Large by Suretek Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Suretek Medical
Sources (1)
- FDA UDI de2549ee-55ed-496e-aa7b-d51baaa6cb0e 34 fields · synced May 30, 2026