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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ZILMASTER FINE CA MINI POINT 3
SHOFU DENTAL CORPORATION
0671
In Commercial Distribution

  • E23506710 ()
0671

  • Dental abrasive point, reusable
ZILMASTER COARSE CA MINI PT 3P
SHOFU DENTAL CORPORATION
0661
In Commercial Distribution

  • E23506610 ()
0661

  • Dental abrasive point, reusable
Hex CA Driver Long, 35 mm
Dentsply Implants Manufacturing GmbH
22549
In Commercial Distribution

  • 07392532002076 ()
22549

  • Surgical screwdriver, reusable
Hex CA Driver Short, 24 mm
Dentsply Implants Manufacturing GmbH
22548
In Commercial Distribution

  • 07392532002069 ()
22548

  • Surgical screwdriver, reusable
O2 DELIVERY KIT, PACU 50/CA
BOUND TREE MEDICAL, LLC
301-PASC107
In Commercial Distribution

  • 00810071630361 ()
  • 00812277039481 ()
  • 00812277038224 ()
301-PASC107

  • Oxygen administration kit, sterile
LHK, CA, CISSS DE LA MONTEREGI
MEDLINE INDUSTRIES, INC.
VASC1745
In Commercial Distribution

  • 40198459327422 ()
  • 10198459327421 ()
VASC1745

  • General surgical procedure kit, non-medicated, single-use
KS 9.0 Kit Monaural CA (beige)
Sonova AG
051-0115-H056
In Commercial Distribution

  • 07613389355994 ()
051-0115-H056

  • Air-conduction hearing aid, receiver-in-canal
KS 9.0 Kit Monaural CA (stone)
Sonova AG
051-0115-D056
In Commercial Distribution

  • 07613389355987 ()
051-0115-D056

  • Air-conduction hearing aid, receiver-in-canal
VITROS Immunodiagnostic Products CA 19-9 Calibrators
ORTHO CLINICAL DIAGNOSTICS
6177752
In Commercial Distribution

  • 20758750034915 ()
  • 10758750034918 ()
6177752

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
MH01,Head, Push Button, CA Burs
Beyes Dental Canada Inc
SL3060
In Commercial Distribution

  • 00837699000734 ()


  • Dental power tool handpiece motorless component
CH04,Head, Latch Type, CA Burs
Beyes Dental Canada Inc
SL2010
In Commercial Distribution

  • 00837699000642 ()


  • Dental power tool handpiece motorless component
CH02,Head, Push Botton, CA Burs
Beyes Dental Canada Inc
SL2008
In Commercial Distribution

  • 00837699000635 ()


  • Dental power tool handpiece motorless component
ENCO EXPLORER 16 .125 TIPS (CA
NORDENT MANUFACTURING INC
EX16-GB
In Commercial Distribution

  • 00840018606265 ()


  • Dental surgical probe, reusable
GENERATOR RDNG3A G3SV5.1 US JP CA
MEDTRONIC, INC.
RDNG3A
In Commercial Distribution

  • 00763000387020 ()


  • Percutaneous radio-frequency ablation system generator
CUSTOM PACK HY10J00R12 ECC SMALL CA
MEDTRONIC, INC.
HY10J00R12
In Commercial Distribution

  • 00763000467449 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11S99R11 CHICO CA 1
MEDTRONIC, INC.
BB11S99R11
In Commercial Distribution

  • 00763000845018 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11S99R12 CHICO CA 1
MEDTRONIC, INC.
BB11S99R12
In Commercial Distribution

  • 00763000848446 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11S99R10 CHICO CA 1
MEDTRONIC, INC.
BB11S99R10
In Commercial Distribution

  • 00763000723989 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11S99R2 CHICO CA 1
MEDTRONIC, INC.
BB11S99R2
In Commercial Distribution

  • 00763000630225 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11S99R15 CHICO CA 1
MEDTRONIC, INC.
BB11S99R15
In Commercial Distribution

  • 00763000927394 ()


  • Cardiopulmonary bypass system blood tubing set
SYRINGE 10CC GREEN CA LAN 50C
DEROYAL INDUSTRIES, INC.
77-400598
In Commercial Distribution

  • 50749756627240 ()
  • 00749756627245 ()


  • Angiographic syringe
ProStim Electrodes, 2" Square, ca/40
ALIMED, INC.
31700
In Commercial Distribution

  • 00733657258332 ()

  • Square
  • Length: 2 Inch
31700

  • Transcutaneous electrical stimulation electrode, single-use
MASK,OX,ADL,7',50/CA
BOUND TREE MEDICAL, LLC
301-180EA
In Commercial Distribution

  • 00810071630811 ()
  • 00810071631214 ()
301-180EA

  • Rebreathing oxygen face mask
CANNULA,ADL,SOFT,25'*,25/CA
BOUND TREE MEDICAL, LLC
301-115
In Commercial Distribution

  • 00810071630644 ()
  • 00810071631047 ()
301-115

  • Tracheostomy tube cannula, single-use
CANNULA,ADL,SOFT,14'*,50/CA
BOUND TREE MEDICAL, LLC
301-114
In Commercial Distribution

  • 00810071630637 ()
  • 00810071631030 ()
301-114

  • Tracheostomy tube cannula, single-use
CANNULA,ADL,25FT,FLARED,25/CA
BOUND TREE MEDICAL, LLC
301-104
In Commercial Distribution

  • 00810071630583 ()
  • 00810071630989 ()
301-104

  • Tracheostomy tube cannula, single-use
CANNULA,ADL,7',FLARED,50/CA
BOUND TREE MEDICAL, LLC
301-100EA
In Commercial Distribution

  • 00810071630569 ()
  • 00810071630965 ()
301-100EA

  • Tracheostomy tube cannula, single-use
2/CA SMOKESTAR 3 PORT FILTER
Conmed Corporation
MH100017
In Commercial Distribution

  • 10845854081686 ()
  • 30845854081680 ()
MH100017

  • Surgical plume evacuation system filter
HUMIDIFIER,DRY,HIGH FLOW,10/CA
BOUND TREE MEDICAL, LLC
301-P3050
In Commercial Distribution

  • 00810071638008 ()
  • 00810071637285 ()
301-P3050EA

  • Non-heated respiratory humidifier
Stability Control, Menu CA +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008470
In Commercial Distribution

  • 00810042683402 ()
18008470

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CA -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008469
In Commercial Distribution

  • 00810042683389 ()
18008469

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CA +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008421
In Commercial Distribution

  • 00810042683273 ()
18008421

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CA -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008420
In Commercial Distribution

  • 00810042683266 ()


  • Multiple drugs of abuse IVD, control
KIT PORTUGUESE HD 1200 AUTOCLAVABLE CA
Smith & Nephew, Inc.
72203408
Not in Commercial Distribution

  • 00885554027464 ()
72203408

  • Laparoscopic surgical procedure kit, non-medicated, single-use
One Piece™ Implant CA Driver
INTRA-LOCK INTERNATIONAL, INC.
OPCAD
In Commercial Distribution

  • D742OPCAD0 ()
OPCAD

  • Dental implant system
Gs/Gw Drive Lock CA Long
INTRA-LOCK INTERNATIONAL, INC.
SDLCAL
In Commercial Distribution

  • D742SDLCAL0 ()
SDLCAL

  • Dental implant system
BONE FILE # 12 CA BELL SHAPED
TELEFLEX INCORPORATED
IPN015677
In Commercial Distribution

  • 24026704291599 ()
  • 04026704291595 ()

  • Double ended Cross serrations
  • Length: 17.8 Centimeter
KM69545

  • Bone file/rasp, manual, reusable
CUSTOM PACK CB5305R1 SUPP W/CA
MEDTRONIC, INC.
CB5305R1
Not in Commercial Distribution

  • 00885074241166 ()


  • Cardiopulmonary bypass system blood tubing set
INFINITY OS CASS,PURPLE,E7,C4,C2 ACC,AW2
HU-FRIEDY MFG. CO., LLC
IMNOS4E/CA
In Commercial Distribution

  • 10889950070731 ()
IMNOS4E/CA

  • Device sterilization/disinfection container, reusable
TSI/ERI Transmucosal Abutment 3.25mm 3.25mm Diameter
OCO BIOMEDICAL INC
TSI/ERI Transmucosal Abutment 3.25mm
In Commercial Distribution

  • D785325CATA0 ()
3.25 CA

  • Dental implant suprastructure, permanent, preformed
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