FDA.reportPublic FDA data

2.5mm Hex Driver

Primary DI
00816101010318
Brand
2.5mm Hex Driver
Company
TOBY ORTHOPAEDICS
Model
NA
Catalog number
TO-DRI-25H
Device description
Drivers are of various tips and handle geometry and are made of stainless steel that is heat treated and passivated. Driver assembly handles are made from machined Radel.
Published
2020-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816101010318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816101010318008161010103188161010103180816101010318

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
305-665-8699sales@tobyortho.com

Regulatory Flags#

DUNS number
024163331
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816101010004Flexor Tendon Sheath Retractor and Suture Retriever / Sheath DilatorNATO-FTRT2026-04-22
00816101017973Cannulated Cruciform Driver with Quick ConnectNATO-DRI-CQCCR2026-04-21
00816101011933WOLF Plate, 70mm, 5 HoleNATO-LBP-0702020-08-15
00816101011940WOLF Plate, 96mm, 7 HoleNATO-LBP-0962020-08-15
00816101011957WOLF Plate, 122mm, 9 HoleNATO-LBP-1222020-08-15
00816101011964WOLF Plate, 148mm, 11 HoleNATO-LBP-1482020-08-15
00816101011971WOLF Plate, 174mm, 13 HoleNATO-LBP-1742020-08-15
00816101011988WOLF Plate, 200mm, 15 HoleNATO-LBP-2002020-08-15
00816101011995WOLF Plate, 226mm, 17 HoleNATO-LBP-2262020-08-15
00816101012008WOLF Plate, 252mm, 19 HoleNATO-LBP-2522020-08-15
00816101012015WOLF Plate, 278mm, 21 HoleNATO-LBP-2782020-08-15
00816101012022WOLF Low Profile Plate, 70mm, 5 HoleNATO-LP-LBP-0702020-08-15
00816101012039WOLF Low Profile Plate, 96mm, 7 HoleNATO-LP-LBP-0962020-08-15
00816101012046WOLF Low Profile Plate, 122mm, 9 HoleNATO-LP-LBP-1222020-08-15
00816101012053WOLF Low Profile Plate, 148mm, 11 HoleNATO-LP-LBP-1482020-08-15
00816101012060WOLF Curved Low Profile Plate, 174mm, 13 HoleNATO-CLP-LBP-1742020-08-15
00816101012077WOLF Curved Low Profile Plate, 200mm, 15 HoleNATO-CLP-LBP-2002020-08-15
00816101012084WOLF Curved Low Profile Plate, 226mm, 17 HoleNATO-CLP-LBP-2012020-08-15
00816101010257PANTERA PLATE, LEFT, 73mmNATO-PHP-L732020-08-13
00816101010264PANTERA PLATE, RIGHT, 73mmNATO-PHP-R732020-08-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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