CxHA™

FDA UDI

Class II (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name: CxHA™ FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: SST FDA UDI
Model / Reference: LS-458-15 FDA UDI
Description: SST FDA UDI

Identifiers

Catalog Number: LS-458-15 FDA UDI
Primary DI / UDI-DI: M711LS458150 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 16 Millimeter FDA UDI
Width — 19 Millimeter FDA UDI
Height — 6 Millimeter FDA UDI
Angle — 8 degree FDA UDI

Category: Bone file/rasp, manual, reusable

CxHA™ by Innovasis, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Innovasis, Inc.

Sources (1)

FDA UDI bc91f0fd-73d8-4a65-be18-04657d1d1c19 36 fields · synced Jun 6, 2026