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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Flow Tube, Easy One Air, Disposable
A-M SYSTEMS, LLC
Flow Tube, Easy One Air - 165760
In Commercial Distribution

  • 00817081024418 ()
  • 00817081024401 ()
165760

  • Breathing mouthpiece, single-use
Flow Tube, Easy One Air, Disposable
A-M SYSTEMS, LLC
Flow Tube, Easy One Air, - 165750
In Commercial Distribution

  • 00817081024395 ()
  • 00817081024388 ()
165750

  • Breathing mouthpiece, single-use
2100B W/ONE PORT ADPT 25.4MMOD
HANS RUDOLPH, INC.
2100
Not in Commercial Distribution

  • 00817136023618 ()
CR1887

  • Pulmonary function valve
EXAFLEX® Base (One pail 30kg)
Gc America Inc.
138331
In Commercial Distribution

  • 10386040005975 ()
138331

  • Silicone dental impression material
Wart Freezer One Step Wart Remover
TARGET CORPORATION
245060245
In Commercial Distribution

  • 10017276228486 ()
  • 00017276228489 ()

  • Height: 155 Millimeter
245060245

  • Wart-removal cryogenic kit
Oasis, One Action Stent Introduction System
COOK IRELAND LTD
G21381
In Commercial Distribution

  • 00827002213814 ()
OA-11.5

  • Endoscopic stent-placement system
Oasis, One Action Stent Introduction System
COOK IRELAND LTD
G25147
In Commercial Distribution

  • 00827002251472 ()
OA-10E

  • Endoscopic stent-placement system
Oasis, One Action Stent Introduction System
COOK IRELAND LTD
G25146
In Commercial Distribution

  • 00827002251465 ()
OA-8.5E

  • Endoscopic stent-placement system
Oasis, One Action Stent Introduction System
COOK IRELAND LTD
G22150
In Commercial Distribution

  • 00827002221505 ()
OA-8.5

  • Endoscopic stent-placement system
Oasis, One Action Stent Introduction System
COOK IRELAND LTD
G21739
In Commercial Distribution

  • 00827002217393 ()
OA-10

  • Endoscopic stent-placement system
Care One DPS DIG Wide-Tip Blue
Ahold U.S.A., Inc.
Digital Wide-Tip Pregnancy Test
In Commercial Distribution

  • 10041520211153 ()
  • 00041520211156 ()
  • 00633472000072 ()
N/A

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Face Mask with One Way Valve
Allied Medical, LLC
L64186
In Commercial Distribution

  • 00026072022993 ()
  • 40026072022991 ()


  • Non-rebreathing oxygen face mask
ONE BY POISE PAD MIX DSP
KIMBERLY-CLARK GLOBAL SALES, INC.
Pad
Not in Commercial Distribution

  • 00036000541786 ()


  • Menstrual pad, unscented
RA ONE STEP PREG TST 2CT
RITE AID CORPORATION
8025004
In Commercial Distribution

  • 00011822887069 ()
  • 60011822887061 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
24 mm Cervical Plate One Level
Ortho Development Corporation
154-5124
Not in Commercial Distribution

  • 00822409023530 ()

  • Length: 24 Millimeter


  • Spinal fixation plate, non-bioabsorbable
22 mm Cervical Plate One Level
Ortho Development Corporation
154-5122
Not in Commercial Distribution

  • 00822409023523 ()

  • Length: 22 Millimeter


  • Spinal fixation plate, non-bioabsorbable
20 mm Cervical Plate One Level
Ortho Development Corporation
154-5120
Not in Commercial Distribution

  • 00822409023516 ()

  • Length: 20 Millimeter


  • Spinal fixation plate, non-bioabsorbable
18 mm Cervical Plate One Level
Ortho Development Corporation
154-5118
Not in Commercial Distribution

  • 00822409023509 ()

  • Length: 18 Millimeter


  • Spinal fixation plate, non-bioabsorbable
16 mm Cervical Plate One Level
Ortho Development Corporation
154-5116
Not in Commercial Distribution

  • 00822409023493 ()

  • Length: 16 Millimeter


  • Spinal fixation plate, non-bioabsorbable
14 mm Cervical Plate One Level
Ortho Development Corporation
154-5114
Not in Commercial Distribution

  • 00822409023486 ()

  • Length: 14 Millimeter


  • Spinal fixation plate, non-bioabsorbable
CM Abutm One Step Hybrid CuZn
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.173
In Commercial Distribution

  • 07899878008903 ()
118.173

  • Dental implant suprastructure, permanent, preformed
TRANSEPITHELIAL ABUTMENT ONE STEP HYBRID COPING
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.085
In Commercial Distribution

  • 07899878008514 ()
118.085

  • Dental implant suprastructure, permanent, preformed
Waist One Stump Panty Open Crotch
Gottfried Medical, Inc.
334
In Commercial Distribution

  • G420334 ()
334

  • Compression/pressure shirt/pants
Miko All Terrain Base, One Size
Drive Devilbiss Healthcare
WCM-2000-2GAT
In Commercial Distribution

  • 00822383001524 ()


  • Freestanding patient positioner, reusable
Air/Water Syringe Tip One Piece
Zoll-Dental
Z-AWST-1
Not in Commercial Distribution

  • 00840105221364 ()


  • Dental delivery system irrigation handpiece
ONE PATIENT STEP SYSTEM 2.0 KIT
LEONE SPA
F6100-02
In Commercial Distribution

  • 08033707051305 ()
F6100-02

  • Orthodontic bracket, metal
Shim for all-in one S5-7 0mm
Medacta International SA
02.18.10.1323
In Commercial Distribution

  • 07630971257283 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S5-7 +1mm
Medacta International SA
02.18.10.1322
In Commercial Distribution

  • 07630971257276 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S3-4 -1mm
Medacta International SA
02.18.10.1319
In Commercial Distribution

  • 07630971257245 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S3-4 +1mm
Medacta International SA
02.18.10.1317
In Commercial Distribution

  • 07630971257221 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S5-7 -2mm
Medacta International SA
02.18.10.1325
In Commercial Distribution

  • 07630971257306 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S5-7 -1mm
Medacta International SA
02.18.10.1324
In Commercial Distribution

  • 07630971257290 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S5-7 +2mm
Medacta International SA
02.18.10.1321
In Commercial Distribution

  • 07630971257269 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S3-4 -2mm
Medacta International SA
02.18.10.1320
In Commercial Distribution

  • 07630971257252 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S3-4 0mm
Medacta International SA
02.18.10.1318
In Commercial Distribution

  • 07630971257238 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S3-4 +2mm
Medacta International SA
02.18.10.1316
In Commercial Distribution

  • 07630971257214 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S1-2 -2mm
Medacta International SA
02.18.10.1315
In Commercial Distribution

  • 07630971257207 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S1-2 -1mm
Medacta International SA
02.18.10.1314
In Commercial Distribution

  • 07630971257191 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S1-2 0mm
Medacta International SA
02.18.10.1313
In Commercial Distribution

  • 07630971257184 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S1-2 +1mm
Medacta International SA
02.18.10.1312
In Commercial Distribution

  • 07630971257177 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Shim for all-in one S1-2 +2mm
Medacta International SA
02.18.10.1311
In Commercial Distribution

  • 07630971257160 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
NTI #4 One Pc Oper Carbide
NTI - Kahla GmbH Rotary Dental Instruments
H1S-014-FG
In Commercial Distribution

  • E310H1S014FG0 ()
  • E310H1S014FG1 ()
H1S-014

  • Carbide dental bur, reusable
NTI #2 One Pc Oper Carbide
NTI - Kahla GmbH Rotary Dental Instruments
H1S-010-FG
In Commercial Distribution

  • E310H1S010FG0 ()
  • E310H1S010FG1 ()
H1S-010

  • Carbide dental bur, reusable
Reusable Jamshidi - One Way Twist Lock
ALPHATEC SPINE, INC.
CI-10729-100
In Commercial Distribution

  • 00840180505151 ()


  • Bone access cannula
ONE PIECE SIDE EXIT GRAFT FUNNEL
ALPHATEC SPINE, INC.
CI-11742
In Commercial Distribution

  • 00840180535622 ()


  • Surgical tamp, reusable
PINNACLE ONE PC REVISION PERIPHERAL DRILL
DEPUY ORTHOPAEDICS, INC.
2274-81-000
In Commercial Distribution

  • 10603295109433 ()
227481000

  • Fluted surgical drill bit, reusable
GMK Sphere All-In One Finishing tray
Medacta International SA
02.12.10.8553
In Commercial Distribution

  • 07630542724121 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
LP Sleeve with Flap - one part
Medacta International SA
03.52.10.0727
In Commercial Distribution

  • 07630542714856 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Face Mask with One Way Valve
Allied Medical, LLC
L64186X
In Commercial Distribution

  • 00026072011522 ()
  • 40260720011528 ()
  • 40026072011520 ()


  • Non-rebreathing oxygen face mask
Face Mask with One Way Valve
Allied Medical, LLC
L64186-N
In Commercial Distribution

  • 00026072011515 ()
  • 40026072011513 ()


  • Non-rebreathing oxygen face mask
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