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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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One Step Conical Reamer
Stryker GmbH
1320-0011
In Commercial Distribution

  • 04546540388940 ()
1320-0011

  • Medullary canal orthopaedic reamer, rigid
ONE LEVEL TISSUE SWEEPER
SPINAL ELEMENTS, INC.
62245-001
In Commercial Distribution

  • 00840606143356 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Cannulae One Piece Mercedes
Avalign Technologies, Inc.
39-CA1MER0330L
In Commercial Distribution

  • 00190776197384 ()


  • Liposuction system cannula, reusable
Cannulae One Piece Standard
Avalign Technologies, Inc.
39-CA1STD0315LL
In Commercial Distribution

  • 00190776196684 ()


  • Liposuction system cannula, reusable
Cannulae One Piece Mercedes
Avalign Technologies, Inc.
39-CA1MER0430L
In Commercial Distribution

  • 00190776196646 ()


  • Liposuction system cannula, reusable
MIS One Step Dilator
Life Spine, Inc.
2016-0185
In Commercial Distribution

  • 00190837056186 ()
2016-0185

  • Endoscopic-access dilator, reusable
One Step Dilator, 3
Life Spine, Inc.
2013-0064
In Commercial Distribution

  • 00190837055325 ()
2013-0064

  • Endoscopic-access dilator, reusable
PHASE ONE DELIVERY TRACECART
MEDLINE INDUSTRIES, INC.
CDS981575
In Commercial Distribution

  • 10884389072998 ()
  • 40884389072999 ()
CDS981575

  • General surgical procedure kit, non-medicated, single-use
OPEN HEART PART ONE
MEDLINE INDUSTRIES, INC.
DYNJ22985B
In Commercial Distribution

  • 40884389018591 ()
  • 10884389018590 ()
DYNJ22985B

  • General surgical procedure kit, non-medicated, reusable
One Step Dilator, 4
Life Spine, Inc.
116-456
In Commercial Distribution

  • 00190837033002 ()
116-456

  • Endoscopic-access dilator, reusable
One Step Dilator, 3
Life Spine, Inc.
116-455
In Commercial Distribution

  • 00190837032999 ()
116-455

  • Endoscopic-access dilator, reusable
One Shot Cuff Inflator
Bracco Diagnostics Inc.
900405
In Commercial Distribution

  • 00815112021221 ()
  • 10815112021228 ()
  • 30815112021222 ()
900405

  • Barium enema catheter
One Shot Cuff Inflator
Bracco Diagnostics Inc.
900405
In Commercial Distribution

  • 30815112020881 ()
  • 10815112020887 ()
  • 00815112020880 ()
900405

  • Barium enema catheter
OVERWATCH® DILATOR ONE
SPINAL ELEMENTS
108-111-1
In Commercial Distribution

  • 00840916137663 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
NON-INSULATED LATERAL DILATOR ONE
SPINAL ELEMENTS
SP-0196-1
In Commercial Distribution

  • 00840916161217 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
kVue One Couch Top
Qfix
RT-4551KV-01
In Commercial Distribution

  • 10841962109120 ()
RT-4551KV-01

  • Indexed-immobilization patient positioning system
14WX12LX5H ONE SIDED RASP
SPINAL ELEMENTS
8178-5-1412X-05P
In Commercial Distribution

  • 00840916149475 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Venus Diamond ONE Kit-PLT
Kulzer GmbH
66081843
Not in Commercial Distribution

  • J014660818430 ()
66081843

  • Dental composite resin
Venus Diamond ONE Kit-Syringe
Kulzer GmbH
66081842
Not in Commercial Distribution

  • J014660818420 ()
66081842

  • Dental composite resin
Venus Pearl One Kit-PLT
Kulzer GmbH
66081841
Not in Commercial Distribution

  • J014660818410 ()
66081841

  • Dental composite resin
Venus Pearl One Kit-Syringe
Kulzer GmbH
66081840
Not in Commercial Distribution

  • J01466081840 ()
66081840

  • Dental composite resin
DRAWER ONE - AIRWAY/BREATHING
MEDLINE INDUSTRIES, INC.
ACC010359A
In Commercial Distribution

  • 10193489504804 ()
  • 40193489504805 ()
ACC010359A

  • General surgical procedure kit, non-medicated, single-use
ONE SOURCE PACK ATLS24
MEDTRONIC, INC.
ATLS24
In Commercial Distribution

  • 00643169108363 ()


  • Autotransfusion system blood component processing set
ONE SOURCE PACK ATLS21
MEDTRONIC, INC.
ATLS21
In Commercial Distribution

  • 00643169108356 ()


  • Autotransfusion system blood component processing set
ONE SOURCE PACK ATLS04
MEDTRONIC, INC.
ATLS04
In Commercial Distribution

  • 00643169108349 ()


  • Autotransfusion system blood component processing set
ONE SOURCE PACK ATLS02
MEDTRONIC, INC.
ATLS02
In Commercial Distribution

  • 00643169108332 ()


  • Autotransfusion system blood component processing set
ONE SOURCE PACK ATLS00
MEDTRONIC, INC.
ATLS00
In Commercial Distribution

  • 00643169108325 ()


  • Autotransfusion system blood component processing set
DILATOR EX1113026 ONE STEP
MEDTRONIC SOFAMOR DANEK, INC.
EX1113026
In Commercial Distribution

  • 00643169433731 ()


  • Laparoscopic access cannula dilator
Tzoar One Adhesive Drape
LIGHTSTONE MEDICAL LLC
LSM-D
In Commercial Distribution

  • 10850017034041 ()
  • 00850017034044 ()


  • Negative-pressure wound therapy system pump, electric
VT• One Suitcase Carilex
CARILEX MEDICAL, INC.
S1004-8050
In Commercial Distribution

  • 04719873694464 ()


  • Negative-pressure wound therapy system pump, electric
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