Identity
- Trade Name
- Spine Needle (16 Gauge) FDA UDI
- Generic Name
- Rigid endoscopic cannula, single-use FDA UDI
- Model / Reference
- DFX-N6/1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846338008017 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Rigid endoscopic cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5150 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid endoscopic cannula, single-use
Spine Needle (16 Gauge) by Elliquence Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- INTELIJET — Smith & Nephew, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Elliquence Llc
Sources (1)
- FDA UDI 75a2288f-6a48-4632-a05f-8199d4b0cc3c 32 fields · synced May 30, 2026