FDA.reportPublic FDA data

NA

Primary DI
10603295246534
Brand
NA
Company
DEPUY INTERNATIONAL LTD
Model
9637-03-000
Catalog number
963703000
Device description
THOMPSON RASP
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10603295246534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329524653410603295246534

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)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
896498813
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
10603295155492SIGMA2960-08-4002960084002018-09-24
10603295155508SIGMA2960-09-4002960094002018-09-24
10603295210320NA8555-06-0008555060002018-09-24
10603295119708AML234-52-10002345210002018-09-24
10603295224341NA9505-01-0329505010322018-09-24
10603295224792LCS9505-01-1199505011192018-09-24
10603295226581PATHWAY9505-01-5229505015222018-09-24
10603295226598NA9505-01-5239505015232018-09-24
10603295226604NA9505-01-5249505015242018-09-24
10603295241065CHARNLEY9620-73-0009620730002018-09-24
10603295026853NA1299-01-0291299010292016-06-30
10603295026952NA1299-01-0581299010582018-09-24
10603295147657C-STEM2580-00-0342580000342018-09-24
10603295147664C-STEM2580-00-0352580000352018-09-24
10603295147671C-STEM2580-00-0362580000362018-09-24
10603295147688C-STEM2580-00-0372580000372018-09-24
10603295147695C-STEM2580-00-0382580000382018-09-24
10603295147701C-STEM2580000392580000392018-09-24
10603295147718C-STEM2580000402580000402018-09-24
10603295147725C-STEM2580000412580000412018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
18257200148448CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148455CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148462CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17
18257200148479CONSTRUX - MINI PEEK VBR,CONSTRUX - MINI PTCOrthofix US LLCHTR2026-07-17