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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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FPPL Care One SPS +/-
Ahold U.S.A., Inc.
FPPL
In Commercial Distribution

  • 00041520863546 ()
  • 10041520863543 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
One Step Wart Freezer
Topco Associates, LLC
003680041112
In Commercial Distribution

  • 10036800411125 ()
  • 00036800411128 ()

  • Height: 155 Millimeter
003680041112

  • Wart-removal cryogenic kit
Chap Style One Leg
Gottfried Medical, Inc.
300
In Commercial Distribution

  • G420300 ()
300

  • Compression/pressure shirt/pants
debritom+ pump, one day
Medaxis AG
2000.0201
In Commercial Distribution

  • 07649996166067 ()
  • 07649996166050 ()
  • B724200002010 ()


  • Surgical irrigation system nozzle
All-in one S5-7 Left
Medacta International SA
02.18.10.1310
In Commercial Distribution

  • 07630971257153 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
All-in one S5-7 Right
Medacta International SA
02.18.10.1309
In Commercial Distribution

  • 07630971257146 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
All-in one S3-4 Left
Medacta International SA
02.18.10.1308
In Commercial Distribution

  • 07630971257139 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
All-in one S3-4 Right
Medacta International SA
02.18.10.1307
In Commercial Distribution

  • 07630971257122 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
All-in one S1-2 Left
Medacta International SA
02.18.10.1306
In Commercial Distribution

  • 07630971257115 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
All-in one S1-2 Right
Medacta International SA
02.18.10.1305
In Commercial Distribution

  • 07630971257108 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
All-in one stabilization peg
Medacta International SA
02.18.10.0373
In Commercial Distribution

  • 07630971256668 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Implant Driver JDPterygo One
J DENTAL CARE SRL
Implant Driver JDPterygo One
In Commercial Distribution

  • 08056591013334 ()
JDID101

  • Dental implant system
PARALLELOMETER INSERT PREMIUM ONE
SWEDEN & MARTINA SPA
PAR-INS-AS
In Commercial Distribution

  • D7701500163 ()
PAR-INS-AS

  • Dental implant abutment trial
ProTENS One Touch Select
COMPASS HEALTH BRANDS CORP.
DI1010-WWM
In Commercial Distribution

  • 80092237618512 ()
  • 00092237618516 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
ONE Tattoo Touch 36-ct
GLOBAL PROTECTION CORP.
112009
In Commercial Distribution

  • 80726893114780 ()
  • 00726893114784 ()


  • Basic male condom, Hevea-latex
ONE Backdoor 3-pack piece
GLOBAL PROTECTION CORP.
11010B3
In Commercial Distribution

  • 10726893114439 ()
  • 00726893114432 ()


  • Basic male condom, Hevea-latex
one blood glucose meter
EPS BIO TECHNOLOGY CORP.
EMV
In Commercial Distribution

  • 00885017000058 ()
  • 01885017000057 ()
  • 10885017000055 ()


  • Glucose monitoring system IVD, home-use
T25 SCREWDRIVER ONE PIECE
Smith & Nephew, Inc.
E0016721-2
In Commercial Distribution

  • 00885556768884 ()
E0016721-2

  • Surgical screwdriver, reusable
ONE PIECEā„¢ TRANSFER
INTRA-LOCK INTERNATIONAL, INC.
OPT2
In Commercial Distribution

  • D742OPT20 ()
OPT2

  • Dental implant system
The Shield, Aquilion ONE
DOMICO MED-DEVICE, LLC
9125
In Commercial Distribution

  • 00810050245524 ()


  • Multifunction body cushion
  • Radiological general body-part positioner
THE SHIELD, AQUILION ONE
DOMICO MED-DEVICE, LLC
9108
In Commercial Distribution

  • 00810050242264 ()


  • 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
ONE PIECE 16MM REAMER
Smith & Nephew, Inc.
E0015581-8
In Commercial Distribution

  • 00885556697375 ()
E0015581-8

  • Medullary canal orthopaedic reamer, rigid
ONE PIECE 15MM REAMER
Smith & Nephew, Inc.
E0015581-7
In Commercial Distribution

  • 00885556697351 ()
E0015581-7

  • Medullary canal orthopaedic reamer, rigid
ONE PIECE 14MM REAMER
Smith & Nephew, Inc.
E0015581-6
In Commercial Distribution

  • 00885556697337 ()
E0015581-6

  • Medullary canal orthopaedic reamer, rigid
ONE PIECE 13MM REAMER
Smith & Nephew, Inc.
E0015581-5
In Commercial Distribution

  • 00885556697320 ()
E0015581-5

  • Medullary canal orthopaedic reamer, rigid
ONE PIECE 12MM REAMER
Smith & Nephew, Inc.
E0015581-4
In Commercial Distribution

  • 00885556697313 ()
E0015581-4

  • Medullary canal orthopaedic reamer, rigid
ONE PIECE 11MM REAMER
Smith & Nephew, Inc.
E0015581-3
In Commercial Distribution

  • 00885556697290 ()
E0015581-3

  • Medullary canal orthopaedic reamer, rigid
ONE PIECE 10MM REAMER
Smith & Nephew, Inc.
E0015581-2
In Commercial Distribution

  • 00885556697283 ()
E0015581-2

  • Medullary canal orthopaedic reamer, rigid
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
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