3DDX Side Opening Kit Keys - 2.0/2.8

FDA UDI

Class I (US FDA UDI)

by 3d Diagnostix, Inc.

Identity

Trade Name: 3DDX Side Opening Kit Keys - 2.0/2.8 FDA UDI
Generic Name: Surgical drill chuck key FDA UDI
Device Name: A hand-held device designed to close and tighten the adjustable jaws of a surgical drill chuck onto a cutting tool, normally a drill bit or other rotational cutting tool, for a firm grip. It is inserted into any one of three side holes that are spaced around the inner barrel of the chuck, and will engage the geared portion of the outer barrel. When rotated, the key will turn the outer barrel, which in turn closes and locks the jaws of the chuck upon the cutting tool. To loosen, the reverse action is taken. It is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device. FDA UDI
Model / Reference: Surgical drill chuck key _ 2.0/2.8 FDA UDI
Description: A hand-held device designed to close and tighten the adjustable jaws of a surgical drill chuck onto a cutting tool, normally a drill bit or other rotational cutting tool, for a firm grip. It is inserted into any one of three side holes that are spaced around the inner barrel of the chuck, and will engage the geared portion of the outer barrel. When rotated, the key will turn the outer barrel, which in turn closes and locks the jaws of the chuck upon the cutting tool. To loosen, the reverse action is taken. It is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850073333037 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Surgical drill chuck key 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

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

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Sterilization Method

Dry Heat Sterilization FDA UDI

Category: Surgical drill chuck key

3DDX Side Opening Kit Keys - 2.0/2.8 by 3d Diagnostix, Inc. — 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: 3d Diagnostix, Inc.

Sources (1)

FDA UDI 0c151390-58c4-4069-a5c1-5c27bbc9e241 33 fields · synced May 30, 2026