FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00763000839604
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X07311050
Device description
MANIPULATOR X07311050 INTRADISCAL SHIM
Published
2025-12-21
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000839604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000839604007630008396047630008396040763000839604

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. 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
00810118343124StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343131StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343148StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343155StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343162StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343179StieberAutomated Medical Products Corp.GAD2026-05-28
00841536147810ThompsonThompson Surgical Instruments, Inc.GAD2026-05-27
G453BH72800PEAK MEDICALPeak Medical Distribution Inc.GAD2026-03-30
07640332476321SCARLET AL-T INSTRUMENTATIONSpineArt SAGAD2025-11-10
07640375234681PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234698PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234704PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234711PERLA ® TL MISSpineArt SAGAD2025-11-10
08904332600681MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600698MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600704MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600711MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
G453TR251320PEAK MEDICALPeak Medical Distribution Inc.GAD2025-10-15
08800071700487Tiger ViewKims Med Co.,Ltd.GAD2025-10-15
08800071017240SignexOSTEONIC CO.,Ltd.GAD2025-06-24
08904332600582MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600599MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600605MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600612MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600629MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600476MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600483MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600490MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08800071700357Tiger ViewKims Med Co.,Ltd.GAD2025-02-10
08800071700371Tiger View Kims Med Co.,Ltd.GAD2025-02-10