Implant Selection Device Set

FDA UDI

Class II (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: Implant Selection Device Set FDA UDI
Generic Name: Surgical depth gauge, reusable FDA UDI
Device Name: A custom engineered set consisting of reusable implant selection device, housed in a sterilizable storage container, that is used during a surgical procedure for the CurvaFix IM Implant. FDA UDI
Model / Reference: CIS-002 FDA UDI
Description: A custom engineered set consisting of reusable implant selection device, housed in a sterilizable storage container, that is used during a surgical procedure for the CurvaFix IM Implant. FDA UDI

Identifiers

Catalog Number: CIS-002 FDA UDI
Primary DI / UDI-DI: 10855068008386 FDA UDI
FDA Product Code: HSB FDA UDI
HWC FDA UDI
GMDN Term: Surgical depth gauge, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
888.3040 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

Yes

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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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: Surgical depth gauge, reusable

Implant Selection Device Set by Curvafix Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical depth gauge, reusable.

Depth Gauge — I.T.S. GmbH · Class I
FO NX Nail System — FIELD ORTHOPAEDICS PTY LTD · Class I
FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
Trigen — Smith & Nephew, Inc. · Class I
HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · 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: Curvafix Inc

Sources (1)

FDA UDI a832ab4e-f045-4dba-a66d-718db68ce2c7 35 fields · synced May 29, 2026