FDA.reportPublic FDA data

DSS™ Reamer

Primary DI
04260148891137
Brand
DSS™ Reamer
Company
Paradigm Spine GmbH
Model
DAT40300
Published
2017-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04260148891137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260148891137042601488911374260148891137

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
537619731
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260148896927DSS HP Polyaxial pedicle screw set, Ø5 x 45mm HPI850452015-10-01
04260148892516DSS NutDPI060112015-10-01
04260148892523DSS Rigid coupler, 20mmDPI700202015-10-01
04260148892554DSS Slotted coupler, 50N/mm stiffness, 26mm longDPI350262015-10-01
04260148892561DSS Slotted coupler, 50N/mm stiffness, 28mm longDPI350282015-10-01
04260148892578DSS Slotted coupler, 50N/mm stiffness, 31mm longDPI350312015-10-01
04260148892585DSS Slotted coupler, 50N/mm stiffness, 35mm longDPI350352015-10-01
04260148892592DSS Rigid coupler, 22-25mmDPI700222015-10-01
04260148892608DSS Rigid coupler, 25-31mmDPI70025 2015-10-01
04260148892615DSS Rigid coupler, 31-43 mmDPI700312015-10-01
04260148892677DSS Pedicle screw set, Ø5.0 x 30mmDPI450302015-10-01
04260148892684DSS Pedicle screw set, Ø5.0 x 35mmDPI450352015-10-01
04260148892691DSS Pedicle screw set, Ø5.0 x 40mmDPI450402015-10-01
04260148892707DSS Pedicle screw set, Ø5.0 x 45mmDPI45045 2015-10-01
04260148892714 DSS Pedicle screw set, Ø5.0 x 50mmDPI450502015-10-01
04260148892721DSS Pedicle screw set, Ø5.0 x 55mmDPI450552015-10-01
04260148892738DSS Pedicle screw set, Ø5.0 x 60mmDPI450602015-10-01
04260148892745DSS Pedicle screw set, Ø6.0 x 30mmDPI46030 2015-10-01
04260148892752DSS Pedicle screw set, Ø6.0 x 35mmDPI46035 2015-10-01
04260148892769DSS Pedicle screw set, Ø6.0 x 40mmDPI460402015-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059386748701Orthopaedic Surgical InstrumentsCITIEFFE SRLHTO2026-05-27
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08800017270272BENCOXCorentec Co., LtdHTO2026-04-02
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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
G079C5090000070Golden Isles Pedicle Screw SystemIntelivation, LLCHTO2022-09-23