Nobel Biocare®

FDA UDI

Class I (US FDA UDI)

by Nobel Biocare AG

Identity

Trade Name: Nobel Biocare® FDA UDI
Generic Name: Surgical drill guide, single-use FDA UDI
Device Name: Guided Pilot Drill Sleeve 2.0mm 20/pkg FDA UDI
Model / Reference: 300441 FDA UDI
Description: Guided Pilot Drill Sleeve 2.0mm 20/pkg FDA UDI

Identifiers

Catalog Number: 300441 FDA UDI
Primary DI / UDI-DI: 17332747009726 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Surgical drill guide, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 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

FDA UDI

Sterilization Method

High-level Disinfectant FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 2.000 Millimeter FDA UDI

Category: Surgical drill guide, single-use

Nobel Biocare® by Nobel Biocare AG — 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: Nobel Biocare AG

Sources (1)

FDA UDI 4fde8de4-e035-4ec4-9b47-cb9b16d30d80 36 fields · synced May 30, 2026