FDA.reportPublic FDA data

Cannulated Universal Quick Connect Handle

Primary DI
00816101013524
Brand
Cannulated Universal Quick Connect Handle
Company
TOBY ORTHOPAEDICS
Model
NA
Catalog number
TO-DRI-M-CQCH
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
00816101013524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816101013524008161010135248161010135240816101013524

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
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00840606191616Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
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03701089540643AMPLITUDEAMPLITUDE SASHXX2026-07-29
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03700569670269Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569674649Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569679859Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569680282Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
03700569680299Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
00824846003205Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
10887587078557NASynthes GmbHHXX2026-07-24