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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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Ion One Touch™ ES Dx - 10190302000864

ION ONE TOUCH ES DX INST
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
ONE TOUCH ES DX
In Commercial Distribution

  • 10190302000864 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

NA - 00613994526380

ONE SOURCE PACK ATLS14 AUTOLOG BT715
MEDTRONIC, INC.
ATLS14
Not in Commercial Distribution

  • 00613994526380 ()


  • Autotransfusion system blood component processing set

NA - 00613994710086

ONE SOURCE KIT ATLS34 AUTOLOG BT720
MEDTRONIC, INC.
ATLS34
In Commercial Distribution

  • 00613994710086 ()


  • Autotransfusion system blood component processing set

iNAP - 04719878320122

iNAP One Sleep Therapy System Console
SOMNICS, INC.
R07-A
In Commercial Distribution

  • 04719878320122 ()
11000-7A

  • Intraoral negative-pressure sleep apnoea unit

iNAP - 04719878320023

iNAP One Sleep Therapy System Console
SOMNICS, INC.
R07-B
In Commercial Distribution

  • 04719878320023 ()
11000-07

  • Intraoral negative-pressure sleep apnoea unit

NA - 04719873696864

VT•200 SYS Global Med One
CARILEX MEDICAL, INC.
S1002-0082
In Commercial Distribution

  • 04719873696864 ()


  • Negative-pressure wound therapy system pump, electric

NA - 04719873696857

VT•200 P.U. Global Med One
CARILEX MEDICAL, INC.
S1002-3082
In Commercial Distribution

  • 04719873696857 ()


  • Negative-pressure wound therapy system pump, electric

Exchange Select - 00614299396432

Exchange Select One Step Ovulation Predictor
SPD SWISS PRECISION DIAGNOSTICS GMBH
One Step Ovulation Predictor
Not in Commercial Distribution

  • 00614299396432 ()
  • 00633472000140 ()
  • 10614299396439 ()


  • Natural conception assistance kit

Adult Non-rebreathing Oxygen Mask - 00628725099675

MASK ADULT NON REBREATHER ONE VALVE
Canadian Hospital Specialties Limited
R-2350
In Commercial Distribution

  • 50628725099670 ()
  • 00628725099675 ()
R-2350

  • Rebreathing oxygen face mask

Adult High Concentration Oxygen Mask with 7’ Saflo Tube - 00628725099521

MASK ADULT NON REBREATHER ONE VALVE
Canadian Hospital Specialties Limited
R-2250S
In Commercial Distribution

  • 50628725099526 ()
  • 00628725099521 ()
R-2250S

  • Rebreathing oxygen face mask

CPAP Filter - 00848530092375

PR System One Style Foam Filter
SUNSET HEALTHCARE SOLUTIONS, INC.
BAY0151009F-1
In Commercial Distribution

  • 00848530092375 ()


  • CPAP/BPAP unit ambient air filter, single-use

CPAP Filter - 00848530092016

PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
ABUC001CF1009-2
In Commercial Distribution

  • 00848530092016 ()


  • CPAP/BPAP unit ambient air filter, single-use

CPAP Filter - 00848530091767

PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
ACPA041CF1009NTPLC
In Commercial Distribution

  • 00848530091767 ()


  • CPAP/BPAP unit ambient air filter, single-use

CPAP Filter - 00848530091750

PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
ACPA050CF1009NTPLC
In Commercial Distribution

  • 00848530091750 ()


  • CPAP/BPAP unit ambient air filter, single-use

Secure IM Nail - 00857915007385

One 70mm x 1.2mm IM Nail
A.M. SURGICAL, INC.
8912-70
In Commercial Distribution

  • 00857915007385 ()
  • 20857915007297 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007378

One 65mm x 1.2mm IM Nail
A.M. SURGICAL, INC.
8912-65
In Commercial Distribution

  • 00857915007378 ()
  • 20857915007280 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007361

One 60mm x 1.2mm IM Nail
A.M. SURGICAL, INC.
8912-60
In Commercial Distribution

  • 00857915007361 ()
  • 10857915007368 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007354

One 55mm x 1.2mm IM Nail
A.M. SURGICAL, INC.
8912-55
In Commercial Distribution

  • 00857915007354 ()
  • 10857915007351 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007347

One 50mm x 1.2mm IM Nail
A.M. SURGICAL, INC.
8912-50
In Commercial Distribution

  • 00857915007347 ()
  • 10857915007344 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007330

One 45mm x 1.2mm IM Nail
A.M. SURGICAL, INC.
8912-45
In Commercial Distribution

  • 00857915007330 ()
  • 10857915007337 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007323

One 40mm x 1.2mm IM Nail
A.M. SURGICAL, INC.
8912-40
In Commercial Distribution

  • 00857915007323 ()
  • 10857915007320 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007316

One 35mm x 1.2mm IM Nail
A.M. SURGICAL, INC.
8912-35
In Commercial Distribution

  • 00857915007316 ()
  • 10857915007313 ()
  • 00857915007538 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007309

One 30mm x 1.2mm IM Nail
A.M. SURGICAL, INC.
8912-30
In Commercial Distribution

  • 00857915007309 ()
  • 10857915007306 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007293

One 70mm x 1.6mm IM Nail
A.M. SURGICAL, INC.
8960-70
In Commercial Distribution

  • 00857915007293 ()
  • 30857915007294 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007286

One 65mm x 1.6mm IM Nail
A.M. SURGICAL, INC.
8960-65
In Commercial Distribution

  • 00857915007286 ()
  • 30857915007287 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007095

One 60mm x 1.6mm IM Nail
A.M. SURGICAL, INC.
8960-60
In Commercial Distribution

  • 00857915007095 ()
  • 10857915007092 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007088

One 55mm x 1.6mm IM Nail
A.M. SURGICAL, INC.
8960-55
In Commercial Distribution

  • 00857915007088 ()
  • 10857915007085 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007071

One 50mm x 1.6mm IM Nail
A.M. SURGICAL, INC.
8960-50
In Commercial Distribution

  • 00857915007071 ()
  • 10857915007078 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007064

One 45mm x 1.6mm IM Nail
A.M. SURGICAL, INC.
8960-45
In Commercial Distribution

  • 00857915007064 ()
  • 10857915007061 ()


  • Orthopaedic bone pin, non-bioabsorbable

Secure IM Nail - 00857915007057

One 40mm x 1.6mm IM Nail
A.M. SURGICAL, INC.
8960-40
In Commercial Distribution

  • 00857915007057 ()
  • 10857915007054 ()


  • Orthopaedic bone pin, non-bioabsorbable

PureSleep - 00851727004020

One PureSleep Anti-Snoring Mouthpiece Kit US
SLEEP SCIENCE PARTNERS, INC.
PSKITA2ES
In Commercial Distribution

  • 00851727004020 ()
PSKITA2ES

  • Mandible-repositioning sleep-disordered breathing orthosis

Trulife - 00645517888606

MANUAL EXPULSION ONE PART HOUSING VALVE
TRULIFE LIMITED
MEV320
In Commercial Distribution

  • 00645517888606 ()


  • External lower-limb prosthesis suspensory component, non-powered

Trulife - 00645517888590

AUTO EXPULSION ONE PART HOUSING VALVE
TRULIFE LIMITED
AEV320
In Commercial Distribution

  • 00645517888590 ()


  • External lower-limb prosthesis suspensory component, non-powered

Venus Bulk Flow ONE - J014660953350

Venus Bulk Flow ONE Value-Kit Syringe
Kulzer GmbH
66095335
In Commercial Distribution

  • J014660953350 ()
66095335

  • Dental composite resin

Venus Bulk Flow ONE - J014660947230

Venus Bulk Flow ONE Syringe Refill
Kulzer GmbH
66094723
In Commercial Distribution

  • J014660947230 ()
66094723

  • Dental composite resin

Venus Bulk Flow ONE - J014660953880

Venus Bulk Flow ONE Value-Kit PLT
Kulzer GmbH
66095388
In Commercial Distribution

  • J014660953880 ()
66095388

  • Dental composite resin

Venus Bulk Flow ONE - J014660947240

Venus Bulk Flow ONE PLT Refill
Kulzer GmbH
66094724
In Commercial Distribution

  • J014660947240 ()
66094724

  • Dental composite resin

Venus Diamond - J014660818490

Venus Diamond PLT Sample Kit ONE
Kulzer GmbH
66081849
In Commercial Distribution

  • J014660818490 ()
66081849

  • Dental composite resin

Venus Diamond - J014660818480

Venus Diamond Syringe Sample Kit ONE
Kulzer GmbH
66081848
In Commercial Distribution

  • J014660818480 ()
66081848

  • Dental composite resin

Venus Pearl - J014660818470

Venus Pearl PLT Sample Kit ONE
Kulzer GmbH
66081847
Not in Commercial Distribution

  • J014660818470 ()
66081847

  • Dental composite resin

Venus Pearl - J014660818460

Venus Pearl Syringe Sample Kit ONE
Kulzer GmbH
66081846
Not in Commercial Distribution

  • J014660818460 ()
66081846

  • Dental composite resin

Venus Diamond - J014660818391

Venus Diamond PLT Refill 20x0.25G ONE
Kulzer GmbH
66081839
In Commercial Distribution

  • J014660818391 ()
66081839

  • Dental composite resin

Venus Diamond - J014660818381

Venus Diamond Syring Refill 1X4G ONE
Kulzer GmbH
66081838
In Commercial Distribution

  • J014660818381 ()
66081838

  • Dental composite resin

Venus Pearl - J014660818371

Venus Pearl PLT Refill 20x0.2G ONE
Kulzer GmbH
66081837
In Commercial Distribution

  • J014660818371 ()
66081837

  • Dental composite resin

Venus Pearl - J014660818370

Venus Pearl PLT Refill 20x0,2G ONE
Kulzer GmbH
66081837
In Commercial Distribution

  • J014660818370 ()
66081837

  • Dental composite resin

Venus Pearl - J014660818361

Venus Pearl Syring Refill 1x3G ONE
Kulzer GmbH
66081836
In Commercial Distribution

  • J014660818361 ()
66081836

  • Dental composite resin

Venus Pearl - J014660818360

Venus Pearl Syringe Refill 1x3G ONE
Kulzer GmbH
66081836
In Commercial Distribution

  • J014660818360 ()
66081836

  • Dental composite resin

Medline Industries, Inc. - 10193489991291

KIM MANIFOLD SET VER ONE - PG
MEDLINE INDUSTRIES, INC.
656608724
In Commercial Distribution

  • 40193489991292 ()
  • 10193489991291 ()
656608724

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327024185

TOTAL HIP ONE AND TWO PACK
MEDLINE INDUSTRIES, INC.
DYNJ67508A
In Commercial Distribution

  • 10195327024185 ()
DYNJ67508A

  • General surgical procedure kit, non-medicated, single-use

NA - 00681490472692

ONE SOURCE PACK ATLS24 AUTOLOG EL240
MEDTRONIC, INC.
ATLS24
In Commercial Distribution

  • 00681490472692 ()


  • Autotransfusion system blood component processing set
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