FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00613994399830
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7081914
Device description
INSTRUMENT 7081914 RATCHET RELEASE
Published
2022-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXPINSTRUMENT, BENDING OR CONTOURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994399830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994399830006139943998306139943998300613994399830

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00199150066919Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2026-03-02
07640187463149Bending Iron SmallBonebridge AGHXP2026-01-16
07640187463156Bending Plier SmallBonebridge AGHXP2026-01-16
07640187463163Cutting PlierBonebridge AGHXP2026-01-16
M711CI1310Opteryx®Innovasis, Inc.HXP2025-06-30
08800071031833SignexOSTEONIC CO.,Ltd.HXP2025-06-27
08809539697369Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
08809539697376Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
08809416068626Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-25
08403207010032Anmuth Medical InternationalAnmuth Medical International, LLCHXP2025-06-09
00763000987336Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2025-02-28
00841435124707TecometTECOMET INC.HXP2024-12-19
03700569652937Newclip InstrumentsNEWCLIP TECHNICSHXP2024-11-07
00763000837099CD Horizon™ ModuLeX™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HXP2024-10-27
07612334236012NASynthes GmbHHXP2024-10-09
07612334236173NASynthes GmbHHXP2024-10-09
07612334236630NASynthes GmbHHXP2024-10-09
07612334236647NASynthes GmbHHXP2024-10-09
00810112597943MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHXP2024-07-31
00810112597974MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHXP2024-07-31
04719878787055“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXP2024-04-15
0088823306976216mm Locking ScrewBIOMET MICROFIXATION, INCHXP2024-03-25
00888515202146BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXP2024-02-28
00810112592641TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXP2024-02-23
00810112592658TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXP2024-02-23
00810112592481TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXP2024-02-14
00840343719265GEN2SURGIX MEDICAL LLCHXP2024-01-05
00841435122581TecometTECOMET INC.HXP2023-11-30
00841435122598TecometTECOMET INC.HXP2023-11-30
00818069014100TecometTECOMET INC.HXP2023-07-31