Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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LATERAL FEMORAL STEM, SIZE 11
Iconacy Orthopedic Implants LLC
01-10001-011-02
In Commercial Distribution

  • M914011000101102 ()
01-10001-011-02

  • Coated femoral stem prosthesis, modular
STANDARD FEMORAL STEM, SIZE 11
Iconacy Orthopedic Implants LLC
01-10001-011-01
In Commercial Distribution

  • M914011000101101 ()
01-10001-011-01

  • Coated femoral stem prosthesis, modular
LATERAL FEMORAL STEM, SIZE 10
Iconacy Orthopedic Implants LLC
01-10001-010-02
In Commercial Distribution

  • M914011000101002 ()
01-10001-010-02

  • Coated femoral stem prosthesis, modular
STANDARD FEMORAL STEM, SIZE 10
Iconacy Orthopedic Implants LLC
01-10001-010-01
In Commercial Distribution

  • M914011000101001 ()
01-10001-010-01

  • Coated femoral stem prosthesis, modular
STANDARD FEMORAL STEM, SIZE 9
Iconacy Orthopedic Implants LLC
01-10001-009-01
In Commercial Distribution

  • M914011000100901 ()
01-10001-009-01

  • Coated femoral stem prosthesis, modular
LATERAL FEMORAL STEM, SIZE 8
Iconacy Orthopedic Implants LLC
01-10001-008-02
In Commercial Distribution

  • M914011000100802 ()

  • Width: 8 Millimeter
01-10001-008-02

  • Coated femoral stem prosthesis, modular
STANDARD FEMORAL STEM, SIZE 8
Iconacy Orthopedic Implants LLC
01-10001-008-01
In Commercial Distribution

  • M914011000100801 ()

  • Width: 8 Millimeter
01-10001-008-01

  • Coated femoral stem prosthesis, modular
McCarthy Proximal Femoral Retractor Custom
Life Instrument Corporation
742-1415-1C
In Commercial Distribution

  • M93074214151C0 ()


  • Hand-held surgical retractor, reusable
ATTUNE PS FEMORAL X-RAY TEMPLATE
DEPUY (IRELAND)
2543-00-001
In Commercial Distribution

  • 10603295327530 ()
254300001

  • Surgical implant template, reusable
ATTUNE CR FEMORAL X-RAY TEMPLATE
DEPUY (IRELAND)
2543-00-000
In Commercial Distribution

  • 10603295327523 ()
254300000

  • Surgical implant template, reusable
P.F.C. SIGMA CR FEMORAL TEMPLATE
DEPUY ORTHOPAEDICS, INC.
XRT-102
In Commercial Distribution

  • 10603295265689 ()
XRT102

  • Surgical implant template, reusable
ATTUNE FEMORAL FINISHING GUIDE SIZE10
DEPUY (IRELAND)
2544-00-030
In Commercial Distribution

  • 10603295395652 ()
254400030

  • Orthopaedic prosthesis implantation positioning instrument, reusable
P.F.C. SIGMA TC3 FEMORAL TEMPLATE
DEPUY ORTHOPAEDICS, INC.
XRT-110
In Commercial Distribution

  • 10603295265702 ()
XRT110

  • Surgical implant template, reusable
SPECIALIST 2 FEMORAL LUG DRILL
DEPUY ORTHOPAEDICS, INC.
96-6200
In Commercial Distribution

  • 10603295247265 ()
966200

  • Fluted surgical drill bit, reusable
UNIVERSAL REVISION FEMORAL BROACH 34mm
DEPUY ORTHOPAEDICS, INC.
96-1684
In Commercial Distribution

  • 10603295239826 ()
961684

  • Orthopaedic broach
UNIVERSAL REVISION FEMORAL BROACH 31mm
DEPUY ORTHOPAEDICS, INC.
96-1683
In Commercial Distribution

  • 10603295239819 ()
961683

  • Orthopaedic broach
UNIVERSAL REVISION FEMORAL BROACH HANDLE
DEPUY ORTHOPAEDICS, INC.
96-1682
In Commercial Distribution

  • 10603295239802 ()
961682

  • Surgical instrument handle, non-torque-limiting
SIGMA FEMORAL ADAPTER HOLDING CLAMP
DEPUY ORTHOPAEDICS, INC.
96-1674
In Commercial Distribution

  • 10603295239796 ()
961674

  • Bone approximation clamp
SIGMA FEMORAL ADAPTER TORQUE WRENCH
DEPUY ORTHOPAEDICS, INC.
96-1673
In Commercial Distribution

  • 10603295239789 ()
961673

  • Surgical torque wrench, reusable
UNIVERSAL REVISION FEMORAL BROACH REAMER
DEPUY ORTHOPAEDICS, INC.
96-1671
In Commercial Distribution

  • 10603295239772 ()
961671

  • Medullary canal orthopaedic reamer, rigid
SIGMA FEMORAL ADAPTER REMOVABLE SHAFT
DEPUY ORTHOPAEDICS, INC.
96-1670
In Commercial Distribution

  • 10603295239765 ()
961670

  • Orthopaedic implant-instrument extension adaptor, reusable
Revision Femoral Rotation Guide – Slim
Medacta International SA
02.07.10.8255
In Commercial Distribution

  • 07630345794536 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
SPECIALIST 2 FEMORAL HOLDING CLAMP
DEPUY ORTHOPAEDICS, INC.
96-6290
In Commercial Distribution

  • 10603295247715 ()
966290

  • Surgical implant/trial-implant/sizer holder, reusable
SPECIALIST 2 FEMORAL LOCATING DEVICE
DEPUY ORTHOPAEDICS, INC.
96-6110
In Commercial Distribution

  • 10603295246831 ()
966110

  • Orthopaedic prosthesis implantation positioning instrument, reusable
CHARNLEY FEMORAL BROACH ROUNDBACK LARGE
DEPUY INTERNATIONAL LTD
9622-52-000
In Commercial Distribution

  • 10603295241744 ()
962252000

  • Orthopaedic broach
CHARNEY FEMORAL BROACH ROUNDBACK SMALL
DEPUY INTERNATIONAL LTD
9622-51-000
In Commercial Distribution

  • 10603295241737 ()
962251000

  • Orthopaedic broach
SIGMA FEMORAL ADAPTER INSTRUMENT CASE
DEPUY ORTHOPAEDICS, INC.
96-1689
In Commercial Distribution

  • 10603295239857 ()
961689

  • Instrument tray, reusable
UNIVERSAL REVISION FEMORAL BROACH 46mm
DEPUY ORTHOPAEDICS, INC.
96-1686
In Commercial Distribution

  • 10603295239840 ()
961686

  • Orthopaedic broach
UNIVERSAL REVISION FEMORAL BROACH 40mm
DEPUY ORTHOPAEDICS, INC.
96-1685
In Commercial Distribution

  • 10603295239833 ()
961685

  • Orthopaedic broach
Femoral head extractor_ deep thread_ZH
Medacta International SA
01.10.10.219
In Commercial Distribution

  • 07630542721892 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Femoral Angiography Drape 84"x159"
EXACT MEDICAL MANUFACTURING, INC.
19326
Not in Commercial Distribution

  • 00817602023449 ()
  • 00817602023210 ()
19326

  • Patient surgical drape, single-use
Trial Femoral Component S7 - RIGHT
Medacta International SA
02.12.10.0014
In Commercial Distribution

  • 07630971202054 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S7 - LEFT
Medacta International SA
02.12.10.0013
In Commercial Distribution

  • 07630971202047 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S6 - RIGHT
Medacta International SA
02.12.10.0012
In Commercial Distribution

  • 07630971202030 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S6 - LEFT
Medacta International SA
02.12.10.0011
In Commercial Distribution

  • 07630971202023 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S5 - RIGHT
Medacta International SA
02.12.10.0010
In Commercial Distribution

  • 07630971202016 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S5 - LEFT
Medacta International SA
02.12.10.0009
In Commercial Distribution

  • 07630971202009 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S4 - RIGHT
Medacta International SA
02.12.10.0008
In Commercial Distribution

  • 07630971201996 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S4 - LEFT
Medacta International SA
02.12.10.0007
In Commercial Distribution

  • 07630971201989 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Trial Femoral Component S3 - RIGHT
Medacta International SA
02.12.10.0006
In Commercial Distribution

  • 07630971201972 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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