arcad®

FDA UDI

Class I (US FDA UDI)

by Novastep

Identity

Trade Name: arcad® FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: Drill Bit Ø3 single-use FDA UDI
Model / Reference: XDB01004D FDA UDI
Description: Drill Bit Ø3 single-use FDA UDI

Identifiers

Catalog Number: XDB01004D FDA UDI
Primary DI / UDI-DI: 03700879504148 FDA UDI
FDA Product Code: HWE FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Cannulated surgical drill bit, single-use

arcad® by Novastep — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Novastep

Sources (1)

FDA UDI 3f1ddda0-274f-4e75-8140-9d72a63f407f 35 fields · synced Jun 8, 2026