Identity
- Trade Name
- AURORA Surgiscope FDA UDI
- Generic Name
- Rigid optical intracranial/spinal endoscope, single-use FDA UDI
- Device Name
- The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB). The AURORA Surgiscope includes the following parts: Sheath, Camera, LEDs (Light Emitting Diodes), Sheath Cable, and Obturator. FDA UDI
- Model / Reference
- AURORA Surgiscope-13 FDA UDI
- Description
- The AURORA Surgiscope System consists of two components: sterile, single use, neurological endoscope called the AURORA Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB). The AURORA Surgiscope includes the following parts: Sheath, Camera, LEDs (Light Emitting Diodes), Sheath Cable, and Obturator. FDA UDI
Identifiers
- Catalog Number
- AURORA Surgiscope-13 FDA UDI
- Primary DI / UDI-DI
- 00860624000448 FDA UDI
- FDA Product Code
- GWG FDA UDI
- GMDN Term
- Rigid optical intracranial/spinal endoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1480 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 13 Centimeter FDA UDI
AURORA Surgiscope by Rebound Therapeutics, Corporation — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Rebound Therapeutics, Corporation
Sources (1)
- FDA UDI ca060349-7e29-42cd-b20e-e4e54e08abeb 37 fields · synced Jun 1, 2026