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Spine Needle (18 Gauge)

FDA UDI

Class II (US FDA UDI)

by Elliquence Llc

Identity

Trade Name
Spine Needle (18 Gauge) FDA UDI
Generic Name
Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use FDA UDI
Model / Reference
DFX-N8/1 FDA UDI

Identifiers

Primary DI / UDI-DI
00846338000776 FDA UDI
FDA Product Code
BSP FDA UDI
GMDN Term
Haematological concentrate/haemostatic agent applicator cannula, endoscopic, 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: Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use

Spine Needle (18 Gauge) by Elliquence Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elliquence Llc

Sources (1)

  • FDA UDI 974809ce-f3bf-4274-b07c-f6045d1f0974 32 fields · synced May 30, 2026