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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RD Head Support - Model 6 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32422ZF-MD
In Commercial Distribution

  • 05420028763537 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support - Model 5 With Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32422-MD
In Commercial Distribution

  • 05420028763520 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support - Model 4 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32421ZF-MD
In Commercial Distribution

  • 05420028763513 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support - Model 3 With Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32421-MD
In Commercial Distribution

  • 05420028763506 ()


  • DNA-based tissue typing IVD, reagent
RD Head Supports for Other Hardware Set of 6 Models
Orfit Industries NV
32708-MD
In Commercial Distribution

  • 05420028763490 ()


  • DNA-based tissue typing IVD, reagent
HP Adapter for S-Type Base Plates with Medium Density Center Plate
Orfit Industries NV
32106
In Commercial Distribution

  • 05420028763278 ()


  • DNA-based tissue typing IVD, reagent
Set of LD Blocks and Wedges 2 blocks 20/40mm + 2 wedges 9°/13.5°
Orfit Industries NV
32709
In Commercial Distribution

  • 05420028762592 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar for Exact™ Couch MRI compatible
Orfit Industries NV
32166
In Commercial Distribution

  • 05420028761816 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support - Model 7 With Lateral Neck Flaps
Orfit Industries NV
32399-MD
In Commercial Distribution

  • 05420028760451 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar for Non-indexed Couch 53cm wide
Orfit Industries NV
33109
In Commercial Distribution

  • 05420028760185 ()


  • DNA-based tissue typing IVD, reagent
Wedge 13.5° angle in CFL
Orfit Industries NV
32424
In Commercial Distribution

  • 05420028759707 ()


  • DNA-based tissue typing IVD, reagent
Prodigy™ Fix MRI compatible
Orfit Industries NV
32066
In Commercial Distribution

  • 05420028758977 ()


  • DNA-based tissue typing IVD, reagent
Prone Breastboard support cushion for contralateral breast
Orfit Industries NV
32054-V2
In Commercial Distribution

  • 05420028757581 ()


  • Radiological whole-body positioner
Adapter Plate for 2-pin Indexing Bar 12 mm Base Plate
Orfit Industries NV
35747/6
In Commercial Distribution

  • 05420028757352 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar for Prodigy™ Couch couch width 53 cm - MR safe
Orfit Industries NV
32165
In Commercial Distribution

  • 05420028756683 ()


  • DNA-based tissue typing IVD, reagent
Paediatric LD Head Support - Model 8 With Lateral Neck Flaps
Orfit Industries NV
35753-80
In Commercial Distribution

  • 05420028756621 ()


  • DNA-based tissue typing IVD, reagent
Head Support Interface for push-pin Base Plates
Orfit Industries NV
32048
In Commercial Distribution

  • 05420028755884 ()


  • DNA-based tissue typing IVD, reagent
Indexing Screws for iBeam® Couch MRI compatible - set of 4
Orfit Industries NV
32126
In Commercial Distribution

  • 05420028755792 ()


  • DNA-based tissue typing IVD, reagent
Upper Extremity Guide and Model
Materialise NV
O-01-0-100000-0021-020
In Commercial Distribution

  • 05420060343391 ()
O-01-0-100000-0021-020

  • Custom-made organ/bone anatomy model/surgical guide kit
Femur Osteotomy Guide and Model
Materialise NV
O-01-0-306000-0011-010
In Commercial Distribution

O-01-0-306000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Tibia/Fibula Osteotomy Guide and Model
Materialise NV
O-01-0-303000-0011-010
In Commercial Distribution

O-01-0-303000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Clavicle Osteotomy Guide and Model
Materialise NV
O-01-0-828000-0011-000
In Commercial Distribution

O-01-0-828000-0011-000

  • Custom-made organ/bone anatomy model/surgical guide kit
Hand Osteotomy Guide and Model
Materialise NV
O-01-0-200000-0011-010
In Commercial Distribution

O-01-0-200000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit
SAFETY BLOOD COLLECTION SET, 21G*3/4" with 12" tubing, standard needle
KB Medical (group), Inc.
SBCN21-1
In Commercial Distribution

  • 00850016172037 ()


  • Blood collection set, invasive
Tube Holder, Pack of 250pcs
KB Medical (group), Inc.
NH01K
In Commercial Distribution

  • 10850016172010 ()
  • 00850016172013 ()


  • Blood collection tube holder, single-use
No Description
Canary Medical USA LLC
43-5570-008-14
In Commercial Distribution

  • 00850015699122 ()


  • Electromechanical device/system transport trolley
The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning.
Canary Medical USA LLC
43-5570-004-14
In Commercial Distribution

  • 00850015699092 ()


  • Surgical implant template, reusable
Hermes TyPEEK Curve Cage 9mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T289023-S
In Commercial Distribution

  • 00850015638855 ()
HRM-T289023-S

  • Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Straight Cage 13mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P2813012-S
In Commercial Distribution

  • 00850015638831 ()
HRM-P2813012-S

  • Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Straight Cage 12mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P2812012-S
In Commercial Distribution

  • 00850015638824 ()
HRM-P2812012-S

  • Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Straight Cage 9mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P289012-S
In Commercial Distribution

  • 00850015638794 ()
HRM-P289012-S

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 8mmx24mm x10mm, 0°
Tyber Medical LLC
HRM-P248010
In Commercial Distribution

  • 00850015638541 ()
HRM-P248010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Curve Cage - 28mm x 12mm x 8mm x 0 °
Tyber Medical LLC
HRM-T288023
In Commercial Distribution

  • 00850015638480 ()
HRM-T288023

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Curve Cage - 26mm x 12mm x 13mm x 0 °
Tyber Medical LLC
HRM-T2613023
In Commercial Distribution

  • 00850015638473 ()
HRM-T2613023

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Curve Cage - 26mm x 12mm x 12mm x 0 °
Tyber Medical LLC
HRM-T2612023
In Commercial Distribution

  • 00850015638466 ()
HRM-T2612023

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Curve Cage - 26mm x 12mm x 11mm x 0 °
Tyber Medical LLC
HRM-T2611023
In Commercial Distribution

  • 00850015638459 ()
HRM-T2611023

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Curve Cage - 26mm x 12mm x 10mm x 0 °
Tyber Medical LLC
HRM-T2610023
In Commercial Distribution

  • 00850015638442 ()
HRM-T2610023

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Curve Cage - 26mm x 12mm x 9mm x 0 °
Tyber Medical LLC
HRM-T269023
In Commercial Distribution

  • 00850015638435 ()
HRM-T269023

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Curve Cage - 26mm x 12mm x 8mm x 0 °
Tyber Medical LLC
HRM-T268023
In Commercial Distribution

  • 00850015638428 ()
HRM-T268023

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 26mm x 10mm x 13mm x 0 °
Tyber Medical LLC
HRM-P2613010
In Commercial Distribution

  • 00850015638411 ()
HRM-P2613010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 26mm x 10mm x 12mm x 0 °
Tyber Medical LLC
HRM-P2612010
In Commercial Distribution

  • 00850015638404 ()
HRM-P2612010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 26mm x 10mm x 11mm x 0 °
Tyber Medical LLC
HRM-P2611010
In Commercial Distribution

  • 00850015638398 ()
HRM-P2611010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 26mm x 10mm x 10mm x 0 °
Tyber Medical LLC
HRM-P2610010
In Commercial Distribution

  • 00850015638381 ()
HRM-P2610010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 26mm x 10mm x 9mm x 0 °
Tyber Medical LLC
HRM-P269010
In Commercial Distribution

  • 00850015638374 ()
HRM-P269010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 26mm x 10mm x 8mm x 0 °
Tyber Medical LLC
HRM-P268010
In Commercial Distribution

  • 00850015638367 ()
HRM-P268010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 24mm x 10mm x 13mm x 0 °
Tyber Medical LLC
HRM-P2413010
In Commercial Distribution

  • 00850015638350 ()
HRM-P2413010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 24mm x 10mm x 12mm x 0 °
Tyber Medical LLC
HRM-P2412010
In Commercial Distribution

  • 00850015638343 ()
HRM-P2412010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 24mm x 10mm x 11mm x 0 °
Tyber Medical LLC
HRM-P2411010
In Commercial Distribution

  • 00850015638336 ()
HRM-P2411010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 24mm x 10mm x 10mm x 0 °
Tyber Medical LLC
HRM-P2410010
In Commercial Distribution

  • 00850015638329 ()
HRM-P2410010

  • Metal-polymer composite spinal interbody fusion cage
Hermes PEEK Straight Cage 24mm x 10mm x 9mm x 0 °
Tyber Medical LLC
HRM-P249010
In Commercial Distribution

  • 00850015638312 ()
HRM-P249010

  • Metal-polymer composite spinal interbody fusion cage
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