FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00763000684044
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
950-146
Device description
INSTRUMENT 950-146 RULER
Published
2025-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS
HTJGAUGE, DEPTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1
HTJGauge, DepthOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000684044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000684044007630006840447630006840440763000684044

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
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
00199150076451Medtronic Reusable InstrumentsX36902502026-10-19
00199150080373Medtronic Reusable InstrumentsX02260452026-10-19
00199150080380Medtronic Reusable InstrumentsX02260462026-10-19
00199150080397Medtronic Reusable InstrumentsX02260472026-10-19
00199150080403Medtronic Reusable InstrumentsX02260502026-10-19
00824846003922Medtronic Reusable InstrumentsEX06260022026-10-19
00824846013082Medtronic Reusable InstrumentsX09074302026-10-19
00824846013600Medtronic Reusable InstrumentsX07260042026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal System557510245402026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal System557510255302026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal System557510255352026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal System557510255402026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal System557510265352026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal System557510265502026-10-16
00824846010739Medtronic Reusable InstrumentsX06260032026-10-18
00824846013495Medtronic Reusable InstrumentsEX07260062026-10-18
00763000786458CD HORIZON® Fenestrated Screw Spinal System65411012026-10-15
00643169236967n/a74806532026-10-11
00643169236974n/a74806522026-10-11
00643169236981n/a74806512026-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886915273U-Motion IIUNITED ORTHOPEDIC CORP.HTJ2026-10-15
G141502302260Carnegie Surgical LLCCarnegie Surgical LLCFTY2026-10-07
10886982345455VOLTSynthes GmbHHTJ2026-09-25
00724995314217V. MuellerSteris CorporationFTY2026-08-21
00190776426750MillenniumAvalign Technologies, Inc.FTY2026-08-19
00840606191609Overwatch PCFSPINAL ELEMENTS, INC.HTJ2026-07-31
00810143906042SURGIPROSSurgipros, LLCFTY2026-07-28
00810212935539SURGIPROSSurgipros, LLCFTY2026-07-28
03700569674250Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
03700569674274Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
B382SD913261200Surgical DirectSurgical Direct, Inc.FTY2026-07-23
B382SD9132841000Surgical DirectSurgical Direct, Inc.FTY2026-07-23
00842188130311Tools - ScrewsTrimed, INC.HTJ2026-07-22
10609576150064Puritan®Puritan Medical ProductsFTY2026-07-20
04719846017436CharderCHARDER ELECTRONIC CO., LTD.FTY2026-07-14
00849987000395SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987001392SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987001460SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987001644SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987001699SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987001804SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987002702SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987002733SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987003037SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987003044SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
06974940307243endophixSuzhou Endophix Co., Ltd.HTJ2026-06-23
08809513720045SAEHAN Hydraulic Pinch GaugeSaehan CorporationHTJ2026-05-18
08809513720069SAEHAN Skinfold CaliperSaehan CorporationFTY2026-05-18
08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
G4250010My MedicalMy Medical Store LLCFTY2026-05-04