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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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Aneroid Kits - 00786511085919

SB-ANEROID BP-FSH W/CASE & SPRAGUE KIT-BX
RASHMAN CORPORATION
SBA2-FSH
In Commercial Distribution

  • 00786511085919 ()


  • Aneroid manual sphygmomanometer

Aneroid Kits - 00786511085797

SB BP-CBL W/CASE & SPRAGUE KIT
RASHMAN CORPORATION
SBA2-CBL
In Commercial Distribution

  • 00786511085797 ()


  • Aneroid manual sphygmomanometer

Aneroid Kits - 00786511083991

ANEROID BP-RHB W/CASE & SPRAGUE KIT-BX
RASHMAN CORPORATION
A2-RHB
In Commercial Distribution

  • 00786511083991 ()


  • Aneroid manual sphygmomanometer

Aneroid Kits - 00786511079543

ANEROID BP-FSB W/CASE & SPRAGUE KIT-BX
RASHMAN CORPORATION
A2-FSB
In Commercial Distribution

  • 00786511079543 ()


  • Aneroid manual sphygmomanometer

Aneroid Kits - 00786511079536

ANEROID BP-FSO W/CASE & SPRAGUE KIT-BX
RASHMAN CORPORATION
A2-FSO
In Commercial Distribution

  • 00786511079536 ()


  • Aneroid manual sphygmomanometer

Aneroid Kits - 00786511079529

ANEROID BP-CMP W/CASE & SPRAGUE KIT-BX
RASHMAN CORPORATION
A2-CMP
In Commercial Distribution

  • 00786511079529 ()


  • Aneroid manual sphygmomanometer

ASCENT - 18257200063475

ASCENT POCTS INSTRUMENT CASE2 CASE #2
Orthofix US LLC
65-1091
In Commercial Distribution

  • 18257200063475 ()


  • Bone-screw internal spinal fixation system, non-sterile

ASCENT - 18257200063468

ASCENT POCTS INSTRUMENT CASE1 CASE #1
Orthofix US LLC
65-1090
In Commercial Distribution

  • 18257200063468 ()


  • Bone-screw internal spinal fixation system, non-sterile

SFS - 18257200057573

SFS REDUCTION SCREW SYSTEM STERILIZATION CASE
Orthofix US LLC
59-1090
In Commercial Distribution

  • 18257200057573 ()


  • Bone-screw internal spinal fixation system, non-sterile

PROVIEW - 18257200066490

PERCUTANEOUS SCREW DELIVERY SYSTEM CASE 2
Orthofix US LLC
70-3091
In Commercial Distribution

  • 18257200066490 ()


  • Growth-correction orthopaedic fixation plate kit

PROVIEW - 18257200066483

PERCUTANEOUS SCREW DELIVERY SYSTEM CASE 1
Orthofix US LLC
70-3090
In Commercial Distribution

  • 18257200066483 ()


  • Growth-correction orthopaedic fixation plate kit

ASCENT LE - 18257200064199

ASCENT LE POCT SYSTEM - AUXILIARY CASE
Orthofix US LLC
66-1093
In Commercial Distribution

  • 18257200064199 ()


  • Bone-screw internal spinal fixation system, non-sterile

ASCENT LE - 18257200064182

ASCENT LE POCT SYSTEM - IMPLANT CASE
Orthofix US LLC
66-1092
In Commercial Distribution

  • 18257200064182 ()


  • Bone-screw internal spinal fixation system, non-sterile

RELIANT - 18257200062416

FOUR LEVEL PLATES CASE RELIANT ACPS
Orthofix US LLC
64-0091
In Commercial Distribution

  • 18257200062416 ()


  • Spinal fixation plate, non-bioabsorbable

NA - 06975843620095

bandages in forest clear plstice case
YUYAO NEW POWER PROMOTION INDUSTRIAL CO., LTD
9425
In Commercial Distribution

  • 16975843620092 ()
  • 06975843620095 ()
  • 26975843620099 ()


  • Adhesive bandage

PILLAR TL - 18257200040070

CURETTE SYSTEM CASE - CONSTRUX PEEK VBR
Orthofix US LLC
46-0093
In Commercial Distribution

  • 18257200040070 ()


  • Metallic spinal interbody fusion cage

CONSTRUX - PEEK VBR - 18257200040049

CONSTRUX PEEK VBR DISC EVAC CASE
Orthofix US LLC
46-0090
In Commercial Distribution

  • 18257200040049 ()


  • Metallic spinal interbody fusion cage

ReLine - 00887517517166

GSB NiMH Battery Pelican Case Beta
Nuvasive, Inc.
BETGSBNIMHBAT
In Commercial Distribution

  • 00887517517166 ()


  • Device sterilization/disinfection container, reusable

SKYHAWK - 18257200126040

SKYHAWK - BASE, INTERBODY 18W IMPLANT CASE
Orthofix US LLC
27-0118B
In Commercial Distribution

  • 18257200126040 ()


  • Metallic spinal interbody fusion cage

SKYHAWK - 18257200125999

TOP TRAY, GENERAL DISCECTOMY CASE #2
Orthofix US LLC
26-8221
In Commercial Distribution

  • 18257200125999 ()


  • Metallic spinal interbody fusion cage

SKYHAWK - 18257200125982

BOTTOM TRAY, GENERAL DISCECTOMY CASE #1
Orthofix US LLC
26-8122
In Commercial Distribution

  • 18257200125982 ()


  • Metallic spinal interbody fusion cage

CENTURION - 18257200125197

CENTURION - BONE SCREW CADDY, OCCIPITAL CASE
Orthofix US LLC
69-8301
In Commercial Distribution

  • 18257200125197 ()


  • Bone-screw internal spinal fixation system, non-sterile

CETRA - 18257200122400

CETRA - BOTTOM TRAY-LEVEL, IMPLANT/INSTRUMENT CASE
Orthofix US LLC
19-1003
In Commercial Distribution

  • 18257200122400 ()


  • Spinal fixation plate, non-bioabsorbable

CETRA - 18257200122394

CETRA - TOP TRAY-LEVEL, IMPLANT/INSTRUMENT CASE
Orthofix US LLC
19-1002
In Commercial Distribution

  • 18257200122394 ()


  • Spinal fixation plate, non-bioabsorbable

LONESTAR - 18257200118526

LONESTAR - TOP LEVEL, IMPLANT / INSTRUMENT CASE
Orthofix US LLC
83-0102
In Commercial Distribution

  • 18257200118526 ()


  • Metallic spinal interbody fusion cage

CONSTRUX - MINI PEEK VBR;CONSTRUX - MINI PTC - 18257200132966

INSTRUMENT CASE, CONSTRUX MINI SPACER SYSTEM
Orthofix US LLC
47-9000
In Commercial Distribution

  • 18257200132966 ()


  • Metallic spinal interbody fusion cage

FENESTRATED SCREWS - 18257200131648

BASE, JANUS FENESTRATED IMPLANT & INSTRUMENT CASE
Orthofix US LLC
36-6300B
In Commercial Distribution

  • 18257200131648 ()


  • Bone-screw internal spinal fixation system, non-sterile

FIREBIRD NXG - 18257200131075

FIREBIRD NXG - REDUCTION IMPLANT / INSTRUMENT CASE
Orthofix US LLC
36-0090
In Commercial Distribution

  • 18257200131075 ()


  • Bone-screw internal spinal fixation system, non-sterile

FORZA XP - 18257200130634

FORZA XP - BASE, IMPLANT/INSTRUMENT CASE
Orthofix US LLC
28-8001
In Commercial Distribution

  • 18257200130634 ()


  • Metallic spinal interbody fusion cage

Aneroid Kits - 00786511077778

ANEROID BP-PBB W/CASE & SPRAGUE KIT-BX
RASHMAN CORPORATION
A2-PBB
In Commercial Distribution

  • 00786511077778 ()


  • Aneroid manual sphygmomanometer
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