Identity
- Trade Name
- Dilator Extractor FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Model / Reference
- 11-2324 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846338005351 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Spinal endoscopic-access system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Spinal endoscopic-access system
Dilator Extractor by Elliquence Llc — 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
- Elliquence Llc
Sources (1)
- FDA UDI f9c38d3c-0b33-44aa-9afb-4536e944203f 32 fields · synced May 31, 2026