FDA.reportPublic FDA data

NA

Primary DI
07611819243804
Brand
NA
Company
Synthes GmbH
Model
352.140
Catalog number
352140
Device description
14.0MM MEDULLARY REAMER HEAD
Published
2016-12-31
Public version status
Update
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
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819243804Direct MarkingGS10
10886982194282PrimaryGS10
H6793521400SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819243804076118192438047611819243804
1088698219428210886982194282

GMDN Terms#

Term, Definition table
TermDefinition
Medullary canal orthopaedic reamer, rigidAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.

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
486711679
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
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094692797Tibial Reamer, Square Tip, Klassic ONE 25/50mmTOTAL JOINT ORTHOPEDICS, INC.HTO2026-06-09
00810030810575InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810582InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810599InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810605InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810612InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810629InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810636InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810643InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810650InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810667InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810674InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810681InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810698InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810704InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810414InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810421InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810438InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810445InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810452InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810469InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810476InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810483InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810490InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810506InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810513InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810520InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810537InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810544InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810551InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31