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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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Black Diamond Pedicle Screw System - B06210101031

STRAIGHT QUICK CONNECT RATCHET HANDLE (IN)
Osseus Fusion Systems, LLC
1010-1031
In Commercial Distribution

  • B06210101031 ()
1010-1031

  • Surgical instrument handle, non-torque-limiting

I-Seed Agx100 - 00813787020037

Loose seeds in a vial - STERILE
THERAGENICS CORPORATION
XX500i
In Commercial Distribution

  • 00813787020037 ()


  • Manual brachytherapy source, permanent implant

TheraSeed - 00813787020013

Loose seeds in a vial - STERILE
THERAGENICS CORPORATION
XX500
In Commercial Distribution

  • 00813787020013 ()


  • Manual brachytherapy source, permanent implant

BOSS Instruments - 00888515209800

Castro Caliper, 1-20mm in .5mm increments
BOSS INSTRUMENTS, LTD., INC.
80-2407
In Commercial Distribution

  • 00888515209800 ()
80-2407

  • Ophthalmic calliper

Spine Instruments - 07630345730053

Slim in situ rod bender left
Medacta International SA
03.51.10.0481
In Commercial Distribution

  • 07630345730053 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Spine Instruments - 07630345730046

Slim in situ rod bender right
Medacta International SA
03.51.10.0480
In Commercial Distribution

  • 07630345730046 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630040775670

Femoral Spacer Tibia in place S1-3
Medacta International SA
02.07.10.9642
In Commercial Distribution

  • 07630040775670 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630040763417

4 in 1 cutting guide S6+
Medacta International SA
02.07.10.3016
In Commercial Distribution

  • 07630040763417 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630040763400

4 in 1 cutting guide S5+
Medacta International SA
02.07.10.3015
In Commercial Distribution

  • 07630040763400 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630040763394

4 in 1 cutting guide S4+
Medacta International SA
02.07.10.3014
In Commercial Distribution

  • 07630040763394 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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