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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2.5MM DRILL BIT - AO
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCG100AO250 ()
MCG100AO-25

  • Fluted surgical drill bit, single-use
BEAM SCREW - 22MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS220 ()
MCG-S22

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 21MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS210 ()
MCG-S21

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 20MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS200 ()
MCG-S20

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 19MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS190 ()
MCG-S19

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 18MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS180 ()
MCG-S18

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 17MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS170 ()
MCG-S17

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 16MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS160 ()
MCG-S16

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW – 15MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS150 ()
MCG-S15

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 14MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS140 ()
MCG-S14

  • Orthopaedic bone screw (non-sliding)
BEAM SCREW - 13MM
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGS130 ()
MCG-S13

  • Orthopaedic bone screw (non-sliding)
RIGHT PLATE, SMALL, WIDE, 2 BEAMS, VARIABLE
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGRF2V0 ()
MCG-RF2V

  • Orthopaedic fixation plate, non-bioabsorbable
Plates MCG-RE2V AND MCG-RF2V GUIDE BLOCK
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGREF2VG0 ()
MCG-REF2VG

  • General internal orthopaedic fixation system implantation kit
RIGHT PLATE, EXTRA SMALL, WIDE, 2 BEAMS, VARIABLE
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGRE2V0 ()
MCG-RE2V

  • Orthopaedic fixation plate, non-bioabsorbable
Plates MCG-RA2V AND MCG-RB2V GUIDE BLOCK
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGRAB2VG0 ()
MCG-RAB2VG

  • General internal orthopaedic fixation system implantation kit
RIGHT PLATE, EXTRA SMALL, NARROW, 2 BEAMS,VARIABLE
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGRA2V0 ()
MCG-RA2V

  • Orthopaedic fixation plate, non-bioabsorbable
RIGHT PLATE, EXTRA SMALL, NARROW, 1 BEAM, FIXED
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGRA1F0 ()
MCG-RA1F

  • Orthopaedic fixation plate, non-bioabsorbable
1.8MM x 24MM LOCKING PEG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGP18240 ()
MCG-P1824

  • Orthopaedic bone screw (non-sliding)
1.8MM x 22MM LOCKING PEG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGP18220 ()
MCG-P1822

  • Orthopaedic bone screw (non-sliding)
1.8MM x 20MM LOCKING PEG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGP18200 ()
MCG-P1820

  • Orthopaedic bone screw (non-sliding)
1.8MM x 18MM LOCKING PEG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGP18180 ()
MCG-P1818

  • Orthopaedic bone screw (non-sliding)
1.8MM x 14MM LOCKING PEG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGP18140 ()
MCG-P1814

  • Orthopaedic bone screw (non-sliding)
1.8MM x 12MM LOCKING PEG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGP18120 ()
MCG-P1812

  • Orthopaedic bone screw (non-sliding)
1.8MM x 11MM LOCKING PEG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGP18110 ()
MCG-P1811

  • Orthopaedic bone screw (non-sliding)
1.8MM x 10MM Locking Peg
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGP18100 ()
MCG-P1810

  • Orthopaedic bone screw (non-sliding)
2.5MM X 24MM NON-LOCKING SCREW
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGN25240 ()
MCG-N2524

  • Orthopaedic bone screw (non-sliding)
2.5MM X 22MM NON-LOCKING SCREW
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGN25220 ()
MCG-N2522

  • Orthopaedic bone screw (non-sliding)
2.5MM X 20MM NON-LOCKING SCREW
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGN25200 ()
MCG-N2520

  • Orthopaedic bone screw (non-sliding)
2.5MM X 18MM NON-LOCKING SCREW
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGN25180 ()
MCG-N2518

  • Orthopaedic bone screw (non-sliding)
2.5MM X 16MM NON-LOCKING SCREW
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGN25160 ()
MCG-N2516

  • Orthopaedic bone screw (non-sliding)
2.5MM X 14MM NON-LOCKING SCREW
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGN25140 ()
MCG-N2514

  • Orthopaedic bone screw (non-sliding)
2.5MM X 13MM NON-LOCKING SCREW
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGN25130 ()
MCG-N2513

  • Orthopaedic bone screw (non-sliding)
2.5MM X 12MM NON-LOCKING SCREW
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGN25120 ()
MCG-N2512

  • Orthopaedic bone screw (non-sliding)
The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)
VERICEL CORPORATION
0
In Commercial Distribution

  • 10850037506207 ()


  • Specimen container mailer, insulated
  • Cell culture medium IVD
No Description
Everly Health, Inc.
0
In Commercial Distribution

  • G7326001 ()


  • Faecal specimen collection kit IVD, home-use
No Description
Wellysis Corp.
0
In Commercial Distribution

  • 08800159500022 ()


  • Telemetric electrocardiographic ambulatory recorder
No Description
Wellysis Corp.
0
In Commercial Distribution

  • 08800159500015 ()


  • Telemetric electrocardiographic ambulatory recorder
Modified Wright-Giemsa Stain Pack
Cardinal Health 200, LLC
0
In Commercial Distribution

  • 50885380152298 ()
  • 10885380152290 ()
CHB3005

  • Laboratory Y-piece connector
Modified Wright Stain Pack
Cardinal Health 200, LLC
0
In Commercial Distribution

  • 50885380152281 ()
  • 10885380152283 ()
CHB3000

  • Laboratory Y-piece connector
No Description
Heine Optotechnik GmbH & Co. KG
0
In Commercial Distribution

  • 04053755129195 ()
F-000.22.771

  • Laryngoscope blade, single-use
No Description
Heine Optotechnik GmbH & Co. KG
0
In Commercial Distribution

  • 04053755200337 ()
F-000.22.110

  • Laryngoscope blade, reusable
No Description
Heine Optotechnik GmbH & Co. KG
0
In Commercial Distribution

  • 04053755200252 ()
F-000.22.120

  • Laryngoscope blade, reusable
No Description
Heine Optotechnik GmbH & Co. KG
0
In Commercial Distribution

  • 04053755200177 ()
F-000.22.100

  • Laryngoscope blade, reusable
NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
0
In Commercial Distribution

  • H9656006056101 ()
  • H9656006056100 ()


  • Angiography kit
No Description
Merete GmbH
0
In Commercial Distribution

  • 04048266131768 ()

  • step: 0 mm
FH14000

  • Orthopaedic fixation plate, non-bioabsorbable
SideStream Reusable and Tuck Mask PT PK, 50 pack.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730001258 ()
1101484

  • Benchtop nebulizer, non-heated
Sidestream Reusable Nebulizers [2], 12-pack
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730001241 ()
1074386

  • Benchtop nebulizer, non-heated
SideStream Reusable Retail Kit, 10-pack
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730001234 ()
1072299

  • Benchtop nebulizer, non-heated
SYSTEM 22 PEDIATRIC AEROSOL MSK SUB ASSY
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730004259 ()
1050430

  • Aerosol face mask, rebreathing, single-use
I-neb PH20 Gold Dosing Kit.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
0
In Commercial Distribution

  • 00383730003740 ()
1119498

  • Ultrasonic nebulizing system
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