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
00763000992521INFINITY OCT SystemG36535102026-09-26
00763000992552INFINITY OCT SystemG36535162026-09-26
00643169016798Medtronic Reusable InstrumentsX06110012022-11-27
00643169016804Medtronic Reusable InstrumentsX06110022022-11-27
00673978816241Medtronic Reusable InstrumentsX06990402022-11-27
00613994423559N/AX07072142022-11-14
00613994423566N/AX07072152022-11-14
00613994423573N/AX07072162022-11-14
00613994423603N/AX07072192022-11-14
00643169588219Medtronic Resuable InstrumentsX08108352022-11-14
00643169860940Medtronic Resuable InstrumentsX07160322022-11-14
00643169860957Medtronic Resuable InstrumentsX07160332022-11-14
00613994107169Medtronic Reusable InstrumentsX08050732022-10-07
00613994230676Medtronic Reusable InstrumentsX07061412022-10-07
00613994404510Medtronic Reusable InstrumentsX07061942022-10-07
00613994507129Medtronic Reusable InstrumentsX08081362022-10-07
00613994507150Medtronic Reusable InstrumentsX08081392022-10-07
00613994507174Medtronic Reusable InstrumentsX08081412022-10-07
00613994838797Medtronic Reusable InstrumentsX06102712022-10-07
00613994838803Medtronic Reusable InstrumentsX06102702022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G4250020My MedicalMy Medical Store LLCFTY2026-05-04
08800322750001AnyPlus®GS Medical Co., Ltd.HTJ2026-04-21