Geo Screw Driver

FDA UDI

Class I (US FDA UDI)

by Geomedi Inc.

Identity

Trade Name: Geo Screw Driver FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Geo Screw Driver is a device used to screw components together during the implantation process. FDA UDI
Model / Reference: SSDATR FDA UDI
Description: Geo Screw Driver is a device used to screw components together during the implantation process. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800028709372 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: Not 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

MRI Safety

MR Conditional FDA UDI

A non-powered tool used to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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: Geomedi Inc.

Sources (1)

FDA UDI f2401ef6-3661-4bfd-88e4-10153a9eea68 34 fields · synced Jul 2, 2026