Darco

FDA UDI

Class I (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name: DARCO FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Device Name: Headed Drill Bit FDA UDI
Model / Reference: 77707514 FDA UDI
Description: Headed Drill Bit FDA UDI

Identifiers

Catalog Number: 77707514 FDA UDI
Primary DI / UDI-DI: 00889797057998 FDA UDI
FDA Product Code: GFG FDA UDI
GMDN Term: Fluted surgical drill bit, reusable 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

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

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Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, reusable

The DARCO fluted surgical drill bit is a high-performance, reusable drill bit designed for general surgical procedures. Made from durable materials and featuring a unique fluted design, this device provides optimal cutting efficiency and comfort during lengthy surgeries.

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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: Wright Medical Technology, Inc.

Sources (1)

FDA UDI 0c519708-01c7-42d2-b118-1f4356ab0d77 36 fields · synced Jul 9, 2026