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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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No Description
KaVo Dental GmbH
0.571.0472
In Commercial Distribution

  • EKAV057104720 ()
clean Brush No 5

  • Ultrasonic dental scaling/debridement system
No Description
Orasure Technologies, Inc.
1154IB
In Commercial Distribution

  • 00608337000726 ()


  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1150IB
In Commercial Distribution

  • 00608337000702 ()


  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1150EB
In Commercial Distribution

  • 00608337000689 ()


  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1124SB
In Commercial Distribution

  • 00608337000665 ()


  • Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1122SB
In Commercial Distribution

  • 00608337000412 ()


  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
No Description
Orasure Technologies, Inc.
1124EB
In Commercial Distribution

  • 00608337000399 ()


  • Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1142IB
In Commercial Distribution

  • 00608337000320 ()


  • Methadone IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1122IB
In Commercial Distribution

  • 00608337000290 ()


  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
No Description
Orasure Technologies, Inc.
1118IB
In Commercial Distribution

  • 00608337000269 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1110IB
In Commercial Distribution

  • 00608337000238 ()


  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1108IB
In Commercial Distribution

  • 00608337000207 ()


  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1104IB
In Commercial Distribution

  • 00608337000184 ()


  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1103IB
In Commercial Distribution

  • 00608337000146 ()


  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Conformity stem, high offset, #5
UNITED ORTHOPEDIC CORP.
1110-3205
In Commercial Distribution

  • 04711605583329 ()
1110-3205

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular
SILICONE CUSHION MASK SIZE#5
BESMED HEALTH BUSINESS CORP.
SM-86251
In Commercial Distribution

  • 04716770862514 ()


  • Cardiopulmonary resuscitation mask, reusable
SILICONE MASK SIZE#5,BLACK
BESMED HEALTH BUSINESS CORP.
SM-86151
In Commercial Distribution

  • 04716770861517 ()


  • Cardiopulmonary resuscitation mask, reusable
No Description
Baylis Médicale Cie Inc
PSZ-200-302
Not in Commercial Distribution

  • 00685447001911 ()


  • Surgical torque wrench, reusable
2440C 5WAY INFLBAL VLV 1.375
HANS RUDOLPH, INC.
2440
Not in Commercial Distribution

  • 00874750008674 ()
112399

  • Pulmonary function valve
2440B 5WAY INFLBAL 1.375/1.125
HANS RUDOLPH, INC.
2440
Not in Commercial Distribution

  • 00874750008667 ()
112398

  • Pulmonary function valve
2440A 5WAY INFLBAL 1.375/22MM
HANS RUDOLPH, INC.
2440
Not in Commercial Distribution

  • 00874750008650 ()
112397

  • Pulmonary function valve
Guideline 4000(TM) 5.0 1m Synchronization Unit Cable
FHC, INC.
C0225-00686
In Commercial Distribution

  • 00873263006863 ()
C0225

  • Neurophysiologic monitoring system
Reference strain
Ssi Diagnostica A/S
82179
In Commercial Distribution

  • 05713106821794 ()
82179

  • Streptococcus pneumoniae culture isolate antigen IVD, control
The inx Medical Nexus Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The inx Medical Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.
INX MEDICAL, LLC
N1101-5
In Commercial Distribution

  • 00861815000469 ()
  • 00861815000407 ()


  • Haemorrhoid ligation set
No Description
BIOANALYTIC GmbH, biomed. Analysentechnik
ETE005-0100
In Commercial Distribution

  • 04061609000439 ()
  • 04061609000644 ()


  • Microcapillary blood collection tube IVD, no additive
No Description
Drägerwerk AG & Co. KGaA
MP05132
In Commercial Distribution

  • 04048675634713 ()


  • Electrocardiographic lead set, reusable
No Description
Drägerwerk AG & Co. KGaA
MP05122
In Commercial Distribution

  • 04048675634096 ()


  • Electrocardiographic lead set, reusable
No Description
Drägerwerk AG & Co. KGaA
MP02741
Not in Commercial Distribution

  • 04048675412120 ()


  • Anaesthesia breathing circuit, single-use
No Description
Drägerwerk AG & Co. KGaA
MP00944
Not in Commercial Distribution

  • 04048675395515 ()


  • Pin-indexed adaptor, reusable
No Description
Drägerwerk AG & Co. KGaA
8418609
In Commercial Distribution

  • 04048675250470 ()
  • 04048675429050 ()


  • Nasal oxygen cannula, CPAP
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