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 Shot Cuff Inflator
Bracco Diagnostics Inc.
900405
In Commercial Distribution

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

  • Barium enema catheter
NIRANIUM ONE TWO THREE
CMP INDUSTRIES LLC
804003
In Commercial Distribution

  • M4828040030 ()


  • Dental casting non-noble alloy
Positioning Board One Piece
INNOMED, INC.
4095-PB
In Commercial Distribution

  • 00840277107107 ()
4095-PB

  • Leg procedure positioner
Metal Cone, one piece
Cynosure, LLC
659-1154
In Commercial Distribution

  • 00841494100544 ()


  • Dermatological frequency-doubled solid-state laser system
BIPOLAR ONE PRONG CORD
SONTEC INSTRUMENTS, INC.
2700-5251
In Commercial Distribution

  • 00192896006133 ()

  • Length: 3 Meter
2700-5251

  • Electrical-only medical device connection cable, reusable
All in one Tap
NEUROSTRUCTURES, INC
10-90-011
In Commercial Distribution

  • 00841508100874 ()


  • General internal orthopaedic fixation system implantation kit
Double-pedal footswitch, one step
Karl Storz GmbH & Co. KG
20014330
In Commercial Distribution

  • 04048551262030 ()


  • Foot-switch, electrical
BPL ONE Respiratory Belt
MEDTEC, INC.
BPL026
In Commercial Distribution

  • 00841439113561 ()
BPL026

  • Radiological whole-body positioner
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
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
ONE STEP INTRODUCER KIT
STRADIS MEDICAL, LLC
525-028
Not in Commercial Distribution

  • M7525250282 ()
  • M7525250281 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 4 French
525-028

  • Cardiac/peripheral vascular guidewire, single-use
TOTAL ONE LAYER INTERMITTENT
MEDLINE INDUSTRIES, INC.
URO4PVCPC16C
In Commercial Distribution

  • 20197344148988 ()
  • 10197344148981 ()
URO4PVCPC16C

  • Intermittent urethral catheterization kit
OCEAN ONE SPINE PACK
MEDLINE INDUSTRIES, INC.
DYNJ84698A
In Commercial Distribution

  • 40198459021948 ()
  • 10198459021947 ()
DYNJ84698A

  • General surgical procedure kit, non-medicated, single-use
Mepitel One 9,5x150cm, US
Mölnlycke Health Care AB
289850
In Commercial Distribution

  • 07323190094394 ()
  • 07323190094400 ()
  • 07323190100569 ()

  • 9.5cm x 150cm


  • Wound-nonadherent dressing, permeable, non-antimicrobial
Mepitel One 13x15 cm
Mölnlycke Health Care AB
289470
In Commercial Distribution

  • 07323190232420 ()
  • 07332551225551 ()
  • 07323190232413 ()

  • 13cm x 15cm


  • Wound-nonadherent dressing, permeable, non-antimicrobial
Mepitel One 17x25 cm
Mölnlycke Health Care AB
289700
In Commercial Distribution

  • 07323190232512 ()
  • 07323190232529 ()
  • 07332551023782 ()

  • 17cm x 25cm


  • Wound-nonadherent dressing, permeable, non-antimicrobial
OCEAN ONE SHOULDER PACK
MEDLINE INDUSTRIES, INC.
DYNJ87620
In Commercial Distribution

  • 40198459049089 ()
  • 10198459049088 ()
DYNJ87620

  • General surgical procedure kit, non-medicated, single-use
One Bottle Drainage System
Cardinal Health, Inc.
8884726100
In Commercial Distribution

  • 10884521214125 ()
  • 20884521214122 ()

  • Total Volume: 2000 Milliliter
8884726100

  • Thoracic suction system
Arm support one hand
Baxter Medical Systems GmbH + Co. KG
4549529
In Commercial Distribution

  • 00887761973398 ()


  • Operating table orthopaedic extension, non-powered
One piece Tool Key
DENTIN IMPLANTS TECHNOLOGIES LTD
DCT-0050
In Commercial Distribution

  • 07290113355996 ()


  • Surgical screwdriver, reusable
One piece Clip mount
DENTIN IMPLANTS TECHNOLOGIES LTD
DCM-0020
In Commercial Distribution

  • 07290113355989 ()


  • Surgical screwdriver, reusable
One Piece Plastic transfer
DENTIN IMPLANTS TECHNOLOGIES LTD
DOP-TR00
In Commercial Distribution

  • 07290113355415 ()


  • Dental implant suprastructure, temporary, preformed, single-use
One Piece Protective Cap
DENTIN IMPLANTS TECHNOLOGIES LTD
DOP-PR00
In Commercial Distribution

  • 07290113355392 ()


  • Dental implant suprastructure, temporary, preformed, single-use
THE SHIELD, AQUILION ONE
DOMICO MED-DEVICE, LLC
9108
In Commercial Distribution

  • 00810050242264 ()


  • Multifunction body cushion
  • Radiological general body-part positioner
The Shield, Aquilion ONE
DOMICO MED-DEVICE, LLC
9125
In Commercial Distribution

  • 00810050245524 ()


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, AQUILION ONE WEDGE
DOMICO MED-DEVICE, LLC
9095
In Commercial Distribution

  • 00810050241403 ()


  • Multifunction body cushion
  • Radiological headrest
Countersink one size D5
UNIQA DENTAL LTD
CD5.0
In Commercial Distribution

  • 07290112858573 ()
CD5.0

  • Fixture/appliance dental drill bit, reusable
2pcs in one pack
GMDASZ manufacturing Co., Ltd.
CSN2713
In Commercial Distribution

  • 06970341670092 ()
  • 6970341677107 ()
  • 6970341674120 ()


  • Transcutaneous electrical stimulation electrode, reusable
Adult One Way Mouthpiece
Jaeger Medical GmbH
36-SST1250
Not in Commercial Distribution

  • 34250892901993 ()
36-SST1250

  • Breathing mouthpiece, single-use
Adult One Way Mouthpiece
Jaeger Medical GmbH
36-SST1000
Not in Commercial Distribution

  • 34250892901986 ()
36-SST1000

  • Breathing mouthpiece, single-use
Adult Mouthpieces one way
CAREFUSION U.K. 232 LIMITED
36-SST1250
Not in Commercial Distribution

  • 34250892980202 ()
36-SST1250

  • Breathing mouthpiece, single-use
Adult Mouthpieces one way
CAREFUSION U.K. 232 LIMITED
36-SST1000
Not in Commercial Distribution

  • 34250892980196 ()
36-SST1000

  • Breathing mouthpiece, single-use
Adult One Way Mouthpiece
Jaeger Medical GmbH
36-SST1250
In Commercial Distribution

  • 34250892903201 ()
36-SST1250

  • Breathing mouthpiece, single-use
Adult One Way Mouthpiece
Jaeger Medical GmbH
36-SST1000
In Commercial Distribution

  • 34250892903195 ()
36-SST1000

  • Breathing mouthpiece, single-use
Square Driver One Piece
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118145400 ()
TK1-0011

  • Dental implant system
ONE GLOSS PS ASSORTMENT
SHOFU DENTAL CORPORATION
0175
In Commercial Distribution

  • E23501750 ()
0175

  • Dental polishing cup, single-use
OCEAN ONE SHOULDER PACK
MEDLINE INDUSTRIES, INC.
DYNJ87620A
In Commercial Distribution

  • 40198459148638 ()
  • 10198459148637 ()
DYNJ87620A

  • General surgical procedure kit, non-medicated, single-use
Tap One Stage 5.6
BLUE SKY BIO LLC
TAPT56
In Commercial Distribution

  • 00810060224670 ()


  • Fixture/appliance dental drill bit, reusable
Tap One Stage 4.8
BLUE SKY BIO LLC
TAPT48
In Commercial Distribution

  • 00810060224663 ()


  • Fixture/appliance dental drill bit, reusable
Tap One Stage 4.1
BLUE SKY BIO LLC
TAPT41
In Commercial Distribution

  • 00810060224656 ()


  • Fixture/appliance dental drill bit, reusable
Tap One Stage 3.3
BLUE SKY BIO LLC
TAPT33
In Commercial Distribution

  • 00810060224649 ()


  • Fixture/appliance dental drill bit, reusable
HOLDER ONE USE NONSTACKABLE
BECTON, DICKINSON AND COMPANY
364815
In Commercial Distribution

  • 50382903648158 ()
  • 00382903648153 ()
  • 30382903648154 ()
364815

  • Blood collection tube holder, single-use
ONE LEVEL TISSUE SWEEPER
SPINAL ELEMENTS, INC.
62245-001
In Commercial Distribution

  • 00840606143356 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Rampart One Standard Spacer
SPINEOLOGY INC.
10-10-76-27
In Commercial Distribution

  • M7404901806 ()

  • Height: 18 Millimeter
490-1806

  • Polymeric spinal fusion cage, sterile
Rampart One Standard Spacer
SPINEOLOGY INC.
10-10-76-26
In Commercial Distribution

  • M7404901805 ()

  • Height: 18 Millimeter
490-1805

  • Polymeric spinal fusion cage, sterile
Rampart One Standard Spacer
SPINEOLOGY INC.
10-10-76-25
In Commercial Distribution

  • M7404901804 ()

  • Height: 18 Millimeter
490-1804

  • Polymeric spinal fusion cage, sterile
Rampart One Standard Spacer
SPINEOLOGY INC.
10-10-76-24
In Commercial Distribution

  • M7404901803 ()

  • Height: 18 Millimeter
490-1803

  • Polymeric spinal fusion cage, sterile
Rampart One Standard Spacer
SPINEOLOGY INC.
10-10-76-23
In Commercial Distribution

  • M7404901802 ()

  • Height: 18 Millimeter
490-1802

  • Polymeric spinal fusion cage, sterile
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