FDA.reportPublic FDA data

RECLAIM

Primary DI
10603295537250
Brand
RECLAIM
Company
DEPUY (IRELAND)
Model
44-00000-32
Catalog number
440000032
Device description
RECLAIM MONOBLOC REVISION HIP SYSTEM REAMER EXTENSION
Published
2023-03-28
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
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295537250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329553725010603295537250

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument adaptor, reusableA connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. 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
989365556
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
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24
10603295080145NA2001-80-5012001805012018-09-24
10603295080770NA2002-25-0002002250002018-09-24
10603295080787NA2002-27-0002002270002018-09-24
10603295080794NA2002-31-0002002310002018-09-24
10603295082057TRI-LOCK2012-03-0052012030052018-09-24
10603295082064TRI-LOCK2012-03-0102012030102018-09-24
10603295082071TRI-LOCK2012-03-0202012030202018-09-24
10603295082088TRI-LOCK2012-03-0302012030302018-09-24
10603295082095TRI-LOCK2012-03-0402012030402018-09-24
10603295082101TRI-LOCK2012-03-0502012030502018-09-24
10603295082118TRI-LOCK2012-03-0602012030602018-09-24
10603295082125TRI-LOCK2012-03-0702012030702018-09-24
10603295082132TRI-LOCK2012-03-0802012030802018-09-24
10603295082149TRI-LOCK2012-03-0902012030902018-09-24
10603295082156TRI-LOCK2012-03-1002012031002018-09-24
10603295082163TRI-LOCK2012-03-1102012031102018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059386748701Orthopaedic Surgical InstrumentsCITIEFFE SRLHTO2026-05-27
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08800017270296BENCOXCorentec Co., LtdHTO2026-04-02
08800017270302BENCOXCorentec Co., LtdHTO2026-04-02
08800017270319BENCOXCorentec Co., LtdHTO2026-04-02
08800017270326BENCOXCorentec Co., LtdHTO2026-04-02
08800017270333BENCOXCorentec Co., LtdHTO2026-04-02
08800017270340BENCOXCorentec Co., LtdHTO2026-04-02
08800017270364BENCOXCorentec Co., LtdHTO2026-04-02
08800017270388BENCOXCorentec Co., LtdHTO2026-04-02
08800017270401BENCOXCorentec Co., LtdHTO2026-04-02
08800017270425BENCOXCorentec Co., LtdHTO2026-04-02
08800017270449BENCOXCorentec Co., LtdHTO2026-04-02
08800017270463BENCOXCorentec Co., LtdHTO2026-04-02
08800017270470BENCOXCorentec Co., LtdHTO2026-04-02
08800017270487BENCOXCorentec Co., LtdHTO2026-04-02
08800017270500BENCOXCorentec Co., LtdHTO2026-04-02
08800017270524BENCOXCorentec Co., LtdHTO2026-04-02
08800017270548BENCOXCorentec Co., LtdHTO2026-04-02
08800017270562BENCOXCorentec Co., LtdHTO2026-04-02
08800017270579BENCOXCorentec Co., LtdHTO2026-04-02
08800017270586BENCOXCorentec Co., LtdHTO2026-04-02
08800017270593BENCOXCorentec Co., LtdHTO2026-04-02
08800017270609BENCOXCorentec Co., LtdHTO2026-04-02
08800017270616BENCOXCorentec Co., LtdHTO2026-04-02
08800017270623BENCOXCorentec Co., LtdHTO2026-04-02
07640187918410TRIGEN MAX ENTRY REAMER 12.5 MM, HALL-JACOBSMPS Micro Precision Systems AGHTO2026-02-24
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