FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00643169060739
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0811305
Device description
RASP X0811305 2MM ANGLEG
Published
2022-10-07
Public version status
Update
Distribution status
Not 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
HTRRASP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169060739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169060739006431690607396431690607390643169060739

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
00763000674397MSB Reusable Instruments98700052026-10-23
00763000749903CD HORIZON® Fenestrated Screw Spinal System557510245302026-10-23
00763000750510CD HORIZON® Fenestrated Screw Spinal System557510275502026-10-23
00763000777500MSB CD HORIZON Spinal System557500465352026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal System557500475452026-10-23
00763000777623MSB CD HORIZON Spinal System557500475502026-10-25
00763000786434MSB CD HORIZON Spinal System65305302026-10-25
00763000857783T2 STRATOSPHERE™ Expandable Corpectomy System436125C2026-10-25
00763000874360MSB SHILLA Growth Guidance System76704312026-10-23
00763000880118MSB Reusable Instruments79670112026-10-23
00199150076451Medtronic Reusable InstrumentsX36902502026-10-19
00199150080373Medtronic Reusable InstrumentsX02260452026-10-19
00199150080380Medtronic Reusable InstrumentsX02260462026-10-19
00199150080397Medtronic Reusable InstrumentsX02260472026-10-19
00199150080403Medtronic Reusable InstrumentsX02260502026-10-19
00824846003922Medtronic Reusable InstrumentsEX06260022026-10-19
00824846013082Medtronic Reusable InstrumentsX09074302026-10-19
00824846013600Medtronic Reusable InstrumentsX07260042026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal System557510245402026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal System557510255302026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435103MillenniumAvalign Technologies, Inc.HTR2026-10-15
00190776435110MillenniumAvalign Technologies, Inc.HTR2026-10-15
00888912103572DJO SURGICALEncore Medical, L.P.HTR2026-10-09
00888912103589DJO SURGICALEncore Medical, L.P.HTR2026-10-09
00840311258635C-Plus PEEK IBF SystemXtant Medical Holdings, Inc.HTR2026-08-26
04054462904037evonosevonos GmbH & Co. KGHTR2026-08-21
04054462904099evonosevonos GmbH & Co. KGHTR2026-08-21
04054462904105evonosevonos GmbH & Co. KGHTR2026-08-21
04054462904006evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904013evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904020evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904051evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904068evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904075evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904082evonosevonos GmbH & Co. KGHTR2026-08-18
04054462904112evonosevonos GmbH & Co. KGHTR2026-08-18
B382SD9213711000Surgical DirectSurgical Direct, Inc.HTR2026-08-07
B382SD9213711010Surgical DirectSurgical Direct, Inc.HTR2026-08-07
B382SD921377200Surgical DirectSurgical Direct, Inc.HTR2026-08-07
B382SD921381030Surgical DirectSurgical Direct, Inc.HTR2026-08-07
00810131885045ION Non CervicalSurgentec, LLCHTR2026-07-28
07640221373687SCALASpineArt SAHTR2026-07-24
00190776421915MillenniumAvalign Technologies, Inc.HTR2026-07-23
18257200103201ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103225ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103232ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103249ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103256ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200103263ALLOGRAFT - CERVICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHTR2026-07-17
18257200148431CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17