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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EPS PACK B BRAUN
Cardinal Health 200, LLC
SAN30EPSB1
In Commercial Distribution

  • 50197106253180 ()
  • 10197106253182 ()
SAN30EPSB1

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
EPS PERCUTANEOUS PACK ILM
Cardinal Health 200, LLC
SANCGEPIL4
In Commercial Distribution

  • 50195594500595 ()
  • 10195594500597 ()
SANCGEPIL4

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
Special Price Pediatric Promo Kit
EXERGEN CORPORATION
TAT-5000S
In Commercial Distribution

  • 10834098000973 ()
124420

  • Infrared patient thermometer, skin
Price Thomas bronchus fcps 22cm
Medicon eG. Chirurgiemechaniker-Genossenschaft
54.57.05
In Commercial Distribution

  • 04046826072483 ()
54.57.05

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Price Muscle Biopsy Clamp,double
Avalign Technologies, Inc.
9-120910
In Commercial Distribution

  • 00190776373993 ()


  • Dressing/utility forceps, tweezers-like, reusable
Indications for FH: The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KANEKA MA-03
In Commercial Distribution

  • 04987671040374 ()


  • Apheresis system
Machine Bag, 5"x5"
Dynarex Corporation
2162
In Commercial Distribution

  • 00616784216232 ()
  • 00616784216225 ()
  • 00616784216218 ()


  • Medical equipment/instrument drape, single-use
RADIOLUCENT CLAMP BASE MACHINE
INTEGRA LIFESCIENCES CORPORATION
437C1073
In Commercial Distribution

  • M268437C10731 ()
  • 10381780255239 ()


  • Skull clamp
Omnigrip Screwdriver Machine 20mm
Nobel Biocare AB
37379
In Commercial Distribution

  • 07332747078657 ()

  • Length: 20.000 Millimeter
37379

  • Surgical screwdriver, reusable
Omnigrip Screwdriver Machine 25mm
Nobel Biocare AB
37380
In Commercial Distribution

  • 07332747078640 ()

  • Length: 25.000 Millimeter
37380

  • Surgical screwdriver, reusable
Omnigrip Screwdriver Machine 30mm
Nobel Biocare AB
37381
In Commercial Distribution

  • 07332747078633 ()

  • Length: 30.000 Millimeter
37381

  • Surgical screwdriver, reusable
Omnigrip Screwdriver Machine 35mm
Nobel Biocare AB
37382
In Commercial Distribution

  • 07332747078626 ()

  • Length: 35.000 Millimeter
37382

  • Surgical screwdriver, reusable
Machine Screwdriver Slot Short
Nobel Biocare AB
DIA 188-0
In Commercial Distribution

  • 07332747017434 ()
DIA 188-0

  • Surgical screwdriver, reusable
Machine Screwdriver Slot Long
Nobel Biocare AB
DIA 189-0
In Commercial Distribution

  • 07332747017427 ()
DIA 189-0

  • Surgical screwdriver, reusable
Machine screwdriver hex long
Nobel Biocare AB
DIA 187-0
In Commercial Distribution

  • 07332747017410 ()
DIA 187-0

  • Surgical screwdriver, reusable
Handle for Machine Instruments
Nobel Biocare AB
29161
In Commercial Distribution

  • 07332747007282 ()
29161

  • Surgical screwdriver, reusable
On1 Screwdriver Machine 21mm
Nobel Biocare AB
38752
In Commercial Distribution

  • 07332747113877 ()

  • Length: 21.000 Millimeter
38752

  • Surgical screwdriver, reusable
Essential Ice Therapy Machine
VIVE HEALTH LLC
RHB3026BLK
In Commercial Distribution

  • 10810113577514 ()
  • 00810113577517 ()


  • Circulating-fluid localized thermal therapy system
ARKON, ANESTHESIA DELIVERY MACHINE
SPACELABS HEALTHCARE (WASHINGTON), INC
ARKON
Not in Commercial Distribution

  • 10841522100017 ()
ARKON

  • Anaesthesia unit, mobile
iGO Screwdriver, Machine 32mm
Neoss AB
51184
In Commercial Distribution

  • 05060440333583 ()
51184

  • Surgical screwdriver, reusable
iGO Screwdriver, Machine 22mm
Neoss AB
51183
In Commercial Distribution

  • 05060440333576 ()
51183

  • Surgical screwdriver, reusable
Neo Screwdriver, Machine 32mm
Neoss AB
51140
In Commercial Distribution

  • 05060440332609 ()
51140

  • Surgical screwdriver, reusable
Neo Screwdriver, Machine 22mm
Neoss AB
51139
In Commercial Distribution

  • 05060440332593 ()
51139

  • Surgical screwdriver, reusable
Portable Suction Machine AC
SUNSET HEALTHCARE SOLUTIONS, INC.
SU100AC
In Commercial Distribution

  • 00848530091378 ()


  • Emergency airway clearance suction pump, electric
Machine Screwdriver 20mm UniGrip
Cochlear Bone Anchored Solutions AB
90380
In Commercial Distribution

  • 09321502040082 ()

  • 20 mm screwdriver
  • Length: 20 Millimeter
90380

  • Surgical screwdriver, reusable
Machine Screwdriver 25mm UniGrip
Cochlear Bone Anchored Solutions AB
90381
In Commercial Distribution

  • 09321502016513 ()

  • Length: 25 Millimeter
  • 25 mm long screwdriver
90381

  • Surgical screwdriver, reusable
Square fit connection, machine
Oticon Medical AB
M50386
In Commercial Distribution

  • 05712149000586 ()
M50386

  • Surgical screwdriver, reusable
MACHINE GRAF PROCESSING -LF
MEDLINE INDUSTRIES, INC.
DYNJ9985295C
In Commercial Distribution

  • 40889942373858 ()
  • 10889942373857 ()
DYNJ9985295C

  • General surgical procedure kit, non-medicated, reusable
Heavy Duty Suction Machine
Drive Devilbiss Healthcare
18600
In Commercial Distribution

  • 00822383111377 ()


  • Airway suction catheter
ACTIVE BOVIE MACHINE PLUG
GRACE MANUFACTURING, INC.
C9019-00
In Commercial Distribution

  • 10801334000332 ()
C9019-00

  • Electrosurgical/ultrasonic surgical system tester interface
Bone Biopsy Set, machine
Philips Ds North America LLC
98960320371
In Commercial Distribution

  • 00884838073234 ()


  • Manual surgical rotary handpiece, reusable
Replacement Ice Machine Pad
VIVE HEALTH LLC
RHB1049PAD
In Commercial Distribution

  • 10810041981520 ()
  • 00810041981523 ()


  • Hot/cold therapy pack, reusable
SLUSH MACHINE COVER, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426009843 ()
  • 30748426009849 ()
  • 00748426009848 ()


  • General-purpose bowl, single-use
SLUSH MACHINE COVER, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426118347 ()
  • 00748426118342 ()


  • General-purpose bowl, single-use
TTCare 100+ Maintenance Machine
HANDPIECE PARTS & REPAIRS, INC.
08090012TB4
In Commercial Distribution

  • 00810988030308 ()
08090012TB4

  • Dental handpiece maintenance unit
Phonak Charger CombiPlus no EPS
Sonova AG
075-0066-10
In Commercial Distribution

  • 07613389457124 ()
075-0066-10

  • Noninvasive device battery charger
Phonak Slim Charger (US EPS)
Sonova AG
075-3024-11
In Commercial Distribution

  • 07613389535952 ()


  • Noninvasive device battery charger
Phonak Slim Charger (no EPS)
Sonova AG
075-3024-10
In Commercial Distribution

  • 07613389535839 ()


  • Noninvasive device battery charger
Phonak Life Charger (no EPS)
Sonova AG
075-3023-10
In Commercial Distribution

  • 07613389527681 ()


  • Noninvasive device battery charger
Phonak Charger Ease no EPS
Sonova AG
075-0080-10
In Commercial Distribution

  • 07613389526714 ()


  • Noninvasive device battery charger
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