FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00673978082837
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
950-146
Device description
INSTRUMENT 950-146 RULER
Published
2022-10-14
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
00673978082837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673978082837006739780828376739780828370673978082837

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
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24
00199150071814Medtronic Reusable InstrumentsEX02261002026-05-24
00199150072057Medtronic Reusable InstrumentsX65500232026-05-23
00199150072064Medtronic Reusable InstrumentsX65500242026-05-23
00199150072576Medtronic Reusable InstrumentsEX02260222026-05-23
00199150074532Medtronic Reusable InstrumentsX12250022026-05-22
00199150074549Medtronic Reusable InstrumentsX12250032026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809986680198Magic RulerInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)FTY2025-10-30
09348215165192Tendon RulerSIGNATURE ORTHOPAEDICS PTY LTDFTY2025-10-10
G79151202DMD000G0WishFIXRed Star Contract Manufacturing Inc.FTY2025-10-06
10197344154654MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
08800071006862Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
08809539690667Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
10326053120500Regard™Resource Optimization & Innovation, L.L.C.FTY2023-08-08
07708604560472SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHTJ2023-01-18
08055727374561DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
08055727374578DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
10603295550273INHANCEDEPUY (IRELAND)HTJ2022-12-09
10665973022427Tech-MedDukal LLCFTY2022-12-06
10665973022434Tech-MedDukal LLCFTY2022-12-06
10810102270686Dermapac, Inc.Dermapac Inc.FTY2022-09-12
10810102270693Dermapac, Inc.Dermapac Inc.FTY2022-09-12
10810102270754Dermapac, Inc.Dermapac Inc.FTY2022-09-12
10810102270761Dermapac, Inc.Dermapac Inc.FTY2022-09-12
10810102270792Dermapac, Inc.Dermapac Inc.FTY2022-09-12
10810102270822Dermapac, Inc.Dermapac Inc.FTY2022-09-12
10810102270853Dermapac, Inc.Dermapac Inc.FTY2022-09-12
10810102271164Dermapac, Inc.Dermapac Inc.FTY2022-09-12
10653160277477CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFTY2022-01-02
08800089415298INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089415328INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089417230INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18