FDA.reportPublic FDA data

DSS™ Coupler Pusher

Primary DI
04260148891007
Brand
DSS™ Coupler Pusher
Company
Paradigm Spine GmbH
Model
DAT30200
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
HXOPusher, Socket

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXOPusher, SocketOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260148891007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260148891007042601488910074260148891007

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
03701313009526KHEIRONS.M.A.I.OHXO2026-07-06
03701313009519KHEIRONS.M.A.I.OHXO2026-07-05
00850011453537Remedy Poly+Plus Acetabular CupOSTEOREMEDIES, LLCHXO2026-06-01
108500705004914.0mm Dual Obturator CURVAFIX, INC.HXO2025-10-22
04719878788106“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2025-10-15
04262494460739N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460746N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460753N/ADoppkon GmbH & Co. KGHXO2025-09-10
04052536081417uCentumUlrich GmbH & Co. KGHXO2025-07-30
10810128461310Hip, Curved Knot PusherT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXO2025-04-29
08800089448739Surgical InstrumentJeil Medical CorporationHXO2024-11-14
00887868582134Affixus®Zimmer, Inc.HXO2024-10-17
00887868582325Affixus®Zimmer, Inc.HXO2024-10-17
08800247360118ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.HXO2024-04-26
04719878786768“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2024-04-15
00613994594891Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXO2023-07-27
08809763500411MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500510MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500527MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500909MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501050MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501357MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501364MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501388MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501395MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501425MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501432MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763505317MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500176MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763500183MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14