Main-AXS Needle-Spinal Simplicity

FDA UDI

Class I (US FDA UDI)

by Mainstream Medical Devices

Identity

Trade Name: Main-AXS Needle-Spinal Simplicity FDA UDI
Generic Name: Bone access channel kit FDA UDI
Device Name: Single-Use, Bone Access Needle, Sterile Trocar Stylus & Blunt Cannula FDA UDI
Model / Reference: 299-08-900 FDA UDI
Description: Single-Use, Bone Access Needle, Sterile Trocar Stylus & Blunt Cannula FDA UDI

Identifiers

Catalog Number: 35-0009-000 FDA UDI
Primary DI / UDI-DI: B908350009000 FDA UDI
FDA Product Code: OCJ FDA UDI
GMDN Term: Bone access channel kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 8 Gauge FDA UDI
Length — 7 Inch FDA UDI

Category: Bone access channel kit

Main-AXS Needle-Spinal Simplicity by Mainstream Medical Devices — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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0.035" x 5" K-Wire Standard — Trilliant Surgical LLC · Class II

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: Mainstream Medical Devices

Sources (1)

FDA UDI dcded93f-abf7-4be5-a952-5de813cef7f0 36 fields · synced May 30, 2026