FDA.report

Geo Screw Driver

Primary DI
08800028709457
Brand
Geo Screw Driver
Company
GEOMEDI INC.
Model
ALDUVR
Device description
Geo Screw Driver is a device used to screw components together during the implantation process.
Published
2025-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800028709457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800028709457088000287094578800028709457

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended 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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
694173762
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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08800028740009Geo Screw DriverSRDNBS2025-12-23
08800028740016Geo Screw DriverSRDNBR2025-12-23
08800028740023Geo Screw DriverSRDNBL2025-12-23
08800028740030Geo Screw DriverSLDNBS2025-12-23
08800028740047Geo Impression Direct CopingIPDC-5040N2025-12-23
08800028740054Geo ArcB Scanbody KitABSK-SET-B2025-12-23
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08800028740085Geo ScrewArcB50NC2025-12-23
08800028740092Geo ScrewArcB50NC52025-12-23
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