FDA.report

Medtronic Reusable Instruments

Primary DI
00763000613792
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX1021013
Device description
SHAVER EX1021013 BOX 13MM
Published
2022-02-11
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

Related Records

Contact Domains

Product Codes

CodeName
FZTCUTTER, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000613792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000613792007630006137927630006137920763000613792

GMDN Terms

TermDefinition
Orthopaedic knifeA hand-held manual surgical instrument designed for cutting/shaping bone during an orthopaedic surgical intervention. It is typically a heavy, one-piece instrument with a sharp, single-edged, strong cutting blade at the distal end available in various shapes and sizes, with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
03662663129053Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCFZT2026-02-11
10889981087968GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981087975GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981087982GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981095970GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981106058CoralSeaspine Orthopedics CorporationFZT2025-12-19
10889981123932GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981259921NorthStarSeaspine Orthopedics CorporationFZT2025-12-19
03662663278096Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-18
03662663217699Vail OCT Spinal Fixation SystemHighridge Medical, LLCFZT2025-12-17
03662663266635Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266642Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266659Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266666Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266673Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266680Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266697Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266703Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266710Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266727Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266734Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266741Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266758Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266765Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266772Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278799Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278805Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278812Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278829Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278836Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16