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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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iBalance TKA PS Tibial Poly Implant Bank
ARTHREX, INC.
RAR-513-PS
Not in Commercial Distribution

  • 00888867213401 ()
  • M150RAR513PS0 ()
RAR-513-PS

  • Surgical implant/trial-implant/sizer holder, reusable
iBalance TKA CR Plus Tibial Poly Bank
ARTHREX, INC.
RAR-503-CP
Not in Commercial Distribution

  • 00888867213364 ()
  • M150RAR503CP0 ()
RAR-503-CP

  • Surgical implant/trial-implant/sizer holder, reusable
5.1mm Cannulated Reamer with Stop
ARTHREX, INC.
AR-2374
In Commercial Distribution

  • 00888867224254 ()
AR-2374

  • Bone-resection orthopaedic reamer, reusable
Single use vaginal speculum with built in light source size small
FTT MEDICAL, INC.
140310
In Commercial Distribution

  • B3961403102 ()
  • B3961403100 ()
  • B3961403101 ()
14-0310

  • Vaginal speculum, single-use
VIP™ Glenoid Reamer, Augmented MGS Large
ARTHREX, INC.
AR-5410-AMGS-L
In Commercial Distribution

  • 00888867409767 ()
AR-5410-AMGS-L

  • Bone-resection orthopaedic reamer, single-use
VIP™ Glenoid Reamer, Augmented MGS Med.
ARTHREX, INC.
AR-5410-AMGS-M
In Commercial Distribution

  • 00888867409750 ()
AR-5410-AMGS-M

  • Bone-resection orthopaedic reamer, single-use
VIP™ Glenoid Reamer, Augmented MGS Small
ARTHREX, INC.
AR-5410-AMGS-S
In Commercial Distribution

  • 00888867409743 ()
AR-5410-AMGS-S

  • Bone-resection orthopaedic reamer, single-use
VIP™ Glenoid Reamer, VaultLock® Small
ARTHREX, INC.
AR-5410-VLS
In Commercial Distribution

  • 00888867409668 ()
AR-5410-VLS

  • Bone-resection orthopaedic reamer, reusable
VIP™ Glenoid Reamer, Paleo
ARTHREX, INC.
AR-5410-P
In Commercial Distribution

  • 00888867409613 ()
AR-5410-P

  • Bone-resection orthopaedic reamer, reusable
VIP™ Glenoid Reamer, VaultLock® XL
ARTHREX, INC.
AR-5410-VLXL
In Commercial Distribution

  • 00888867392311 ()
AR-5410-VLXL

  • Bone-resection orthopaedic reamer, reusable
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