Handled Cannula

FDA UDI

Class I (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: Handled Cannula FDA UDI
Generic Name: Orthopaedic implantation sleeve, reusable FDA UDI
Device Name: A hand-held stainless steel tube used during a CurvaFix Implant implantation procedure to maintain direct access to the surgical site, protect the patient soft tissue, and facilitate the acceptance of orthopaedic instrumentation into the surgical site. FDA UDI
Model / Reference: CHC-001 FDA UDI
Description: A hand-held stainless steel tube used during a CurvaFix Implant implantation procedure to maintain direct access to the surgical site, protect the patient soft tissue, and facilitate the acceptance of orthopaedic instrumentation into the surgical site. FDA UDI

Identifiers

Catalog Number: CHC-001 FDA UDI
Primary DI / UDI-DI: 10855068008164 FDA UDI
FDA Product Code: FZX FDA UDI
HWC FDA UDI
HSB FDA UDI
GMDN Term: Orthopaedic implantation sleeve, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
888.3040 FDA UDI
888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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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

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implantation sleeve, reusable

Handled Cannula by Curvafix Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Salvo® Spine System — Spine Wave, Inc. · Class I
DRILL SLEEVE — Biomet Orthopedics, 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 I	Pending data

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Manufacturer

Manufacturer: Curvafix Inc

Sources (1)

FDA UDI dd1feab5-83fc-4a73-be1e-ef76ffa34281 35 fields · synced Jun 8, 2026