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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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Starter Proximal Humeral Broach #H5
LIMACORPORATE SPA
9015.04.005
In Commercial Distribution

  • 08033390138093 ()

  • #H5
9015.04.005

  • Orthopaedic broach
CUSTOM PACK 7S49R2 4PK VAC APK
MEDTRONIC, INC.
7S49R2
In Commercial Distribution

  • 20643169613366 ()
  • 00643169613355 ()


  • Cardiopulmonary bypass system blood tubing set
H5/H5
Zoll-Dental
S-H5/H5
In Commercial Distribution

  • 00840105213635 ()


  • Manual dental scaler, reusable
Starter Distal Humeral Broach #H5 - RIGHT
LIMACORPORATE SPA
9015.04.051
In Commercial Distribution

  • 08033390138277 ()

  • #H5 - RIGHT
9015.04.051

  • Orthopaedic broach
Starter Distal Humeral Broach #H5 - LEFT
LIMACORPORATE SPA
9015.04.050
In Commercial Distribution

  • 08033390138215 ()

  • #H5 - LEFT
9015.04.050

  • Orthopaedic broach
25ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5625
In Commercial Distribution

  • 20841305111442 ()
  • 10841305111438 ()
SE5625

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)
23ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5623
In Commercial Distribution

  • 20841305111428 ()
  • 10841305111414 ()
SE5623

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)
#5 Hemostat (1x2)
HU-FRIEDY MFG. CO., LLC
H5
In Commercial Distribution

  • 10889950013363 ()
H5

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
H5
Zoll-Dental
S-H5
In Commercial Distribution

  • 00840105213680 ()


  • Manual dental scaler, reusable
#H5/H5 SCALER DE, #7 COLOR
HU-FRIEDY MFG. CO., LLC
SC11377
In Commercial Distribution

  • 10889950137779 ()


  • Manual dental scaler, reusable
SATIN STEEL H5/H5 SCALER DE
HU-FRIEDY MFG. CO., LLC
SC11376
In Commercial Distribution

  • 10889950090760 ()


  • Manual dental scaler, reusable
#H5/H5 SCALER DE - 2 HDL
HU-FRIEDY MFG. CO., LLC
SC1137
In Commercial Distribution

  • 10889950090753 ()


  • Manual dental scaler, reusable
Headgear for YUWELL Sleep Apnea Breathing Therapy Mask (YP-01)
Suzhou Yuyue Medical Technology Co., Ltd.
H5
In Commercial Distribution

  • 26922166511511 ()
  • 06922166511517 ()


  • Orthodontic chin cap/cup
Periodontal Instrument, Scaler, Double Ended
A. TITAN INSTRUMENTS, INC.
H5
In Commercial Distribution

  • 00841685107376 ()


  • Manual dental scaler, reusable
U15/H5
Zoll-Dental
S-U15/H5
In Commercial Distribution

  • 00840105214465 ()


  • Manual dental scaler, reusable
H5/XS-15
Zoll-Dental
S-H5/XS15
In Commercial Distribution

  • 00840105213673 ()


  • Manual dental scaler, reusable
H5/U15
Zoll-Dental
S-H5/U15
In Commercial Distribution

  • 00840105213666 ()


  • Manual dental scaler, reusable
H5/J33
Zoll-Dental
S-H5/J33
In Commercial Distribution

  • 00840105213659 ()


  • Manual dental scaler, reusable
H5/J30
Zoll-Dental
S-H5/J30
In Commercial Distribution

  • 00840105213642 ()


  • Manual dental scaler, reusable
H5/H48
Zoll-Dental
S-H5/H48
In Commercial Distribution

  • 00840105213628 ()


  • Manual dental scaler, reusable
H5/H47
Zoll-Dental
S-H5/H47
In Commercial Distribution

  • 00840105213611 ()


  • Manual dental scaler, reusable
Hourigan H5
Zoll-Dental
ELE-H5
In Commercial Distribution

  • 00840105203438 ()


  • Dental elevator, tooth/root
Flowmeter, calibration, gas
IMT Analytics AG
304.555.000
In Commercial Distribution

  • 07640214642165 ()
  • 07640214642417 ()


  • Anaesthesia/respiratory gas flowmeter tester
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM531
In Commercial Distribution

  • 06970935830543 ()


  • Pelvic floor exercise biofeedback device
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM530
In Commercial Distribution

  • 06970935830536 ()


  • Pelvic floor exercise biofeedback device
H5/H5 DE Scaler, Resin Eight Handle
HU-FRIEDY MFG. CO., LLC
SC11378
In Commercial Distribution

  • 10889950138448 ()


  • Manual dental scaler, reusable
Also covers the following minor/medium updates: v3.1.0: (01)00860001471731(11)210526(10)310; v3.1.1 (01)00860001471731(11)210604(10)311; v3.1.2 (01)00860001471731(11)210625(10)312; v3.2.0 (01)00860001471731(11)210713(10)320; v3.2.1. (01)00860001471731(11)210804(10)321; v3.2.2 (01)00860001471731(11)210917(10)322; v3.2.3 (01)00860001471731(11)211026(10)323 ;v3.2.4 (01)00860001471731(11)211123(10)324; v3.4.0: (01)00860001471731(11)220609(10)340; v3.5.1 (01)00860001471731(11)220718(10)351; v3.6.0 (01)00860001471731(11)220926(10)360; v3.6.2(01)00860001471731(11)221024(10)362; v3.7.0(01)00860001471731(11)221116(10)370; v3.8.0(01)00860001471731(11)221215(10)380; v3.8.1(01)00860001471731(11)230127(10)381; v3.9.0(01)00860001471731(11)230217(10)390; v3.9.1(01)00860001471731(11)230417(10)391; v3.9.2 (01)00860001471731(11)230609(10)392; v3.9.3 (01)00860001471731(11)230714(10)393; v3.10.0 (01)00860001471731(11)231013(10)3100
AMPLIFON SPA
Android v3
In Commercial Distribution

  • 00860001471731 ()


  • Hearing aid/implant system remote control
Also covers the following minor/medium updates: v3.1.0 (01)00860001471724(11)210526(10)310; v3.1.1 (01)00860001471724(11)210604(10)311; v3.1.2 (01)00860001471724(11)210625(10)312; v3.2.0 (01)00860001471724(11)210713(10)320; v3.2.1. (01)00860001471724(11)210804(10)321; v3.2.2 (01)00860001471724(11)210917(10)322; v3.2.3 (01)00860001471724(11)211026(10)323 ;v3.2.4 (01)00860001471724(11)211123(10)324; v3.7.0 (01)00860001471724(11) 221116(10)370; v3.6.2 (01)00860001471724(11) 221024(10)362; v3.4.0:(01)00860001471724(11)220609(10)350; v3.5.1(01)00860001471724(11)220718(10)351; v3.6.0 (01)00860001471724(11) 220926(10)360; v3.8.0 (01)00860001471724(11) 221215(10)380; v3.8.1 (01)00860001471724(11) 230127(10)381; v3.9.0 (01)00860001471724(11) 230217(10)390; v3.9.1 (01)00860001471724(11) 230417(10)391; v3.9.2 (01)00860001471724(11) 230609(10)392; v3.9.3 (01)00860001471724(11) 230714(10)393; v3.10.0 (01)00860001471724(11) 231013(10)3100
AMPLIFON SPA
iOS v3
In Commercial Distribution

  • 00860001471724 ()


  • Hearing aid/implant system remote control
App Android 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471717(11)190807(10)202; v2.0.3: (01)00860001471717(11)190927(10)203; v2.0.4: (01)00860001471717(11)191014(10)204; v2.0.5: (01)00860001471717(11)191218(10)205; v2.0.6: (01)00860001471717(11)200227(10)206; v2.1.0: (01)00860001471717(11)200420(10)210; v2.2.1: (01)00860001471717(11)200729(10)221; v2.3.0: (01)00860001471717(11)201217(10)230; v2.3.1: (01)00860001471717(11)210205(10)231; v2.3.2: (01)00860001471717(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471717 ()


  • Hearing aid/implant system remote control
App IOS 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471700(11)190807(10)202; v2.0.3: (01)00860001471700(11)190927(10)203; v2.0.4: (01)00860001471700(11)191014(10)204; v2.0.5: (01)00860001471700(11)191218(10)205; v2.0.6:(01)00860001471700(11)200227(10)206; v2.1.0: (01)00860001471700(11)200528(10)210; v2.2.1: (01)00860001471700(11)200729(10)221; v2.3.0: (01)00860001471700(11)201217(10)230; v2.3.1: (01)00860001471700(11)210205(10)231; v2.3.2: (01)00860001471700(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471700 ()


  • Hearing aid/implant system remote control
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830350
In Commercial Distribution

  • 00191506014902 ()

  • Balloon Diameter: 3.50 Millimeter
  • Balloon Length: 30 Millimeter
H7493960830350

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830300
In Commercial Distribution

  • 00191506014896 ()

  • Balloon Length: 30 Millimeter
  • Balloon Diameter: 3 Millimeter
H7493960830300

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830270
In Commercial Distribution

  • 00191506014889 ()

  • Balloon Length: 30 Millimeter
  • Balloon Diameter: 2.75 Millimeter
H7493960830270

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830250
In Commercial Distribution

  • 00191506014872 ()

  • Balloon Diameter: 2.50 Millimeter
  • Balloon Length: 30 Millimeter
H7493960830250

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830220
In Commercial Distribution

  • 00191506014865 ()

  • Balloon Diameter: 2.25 Millimeter
  • Balloon Length: 30 Millimeter
H7493960830220

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830200
In Commercial Distribution

  • 00191506014858 ()

  • Balloon Diameter: 2 Millimeter
  • Balloon Length: 30 Millimeter
H7493960830200

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960820400
In Commercial Distribution

  • 00191506014841 ()

  • Balloon Length: 20 Millimeter
  • Balloon Diameter: 4 Millimeter
H7493960820400

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960820350
In Commercial Distribution

  • 00191506014834 ()

  • Balloon Diameter: 3.50 Millimeter
  • Balloon Length: 20 Millimeter
H7493960820350

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960820300
In Commercial Distribution

  • 00191506014827 ()

  • Balloon Length: 20 Millimeter
  • Balloon Diameter: 3 Millimeter
H7493960820300

  • Coronary angioplasty balloon catheter, drug-coated
Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960820270
In Commercial Distribution

  • 00191506014810 ()

  • Balloon Diameter: 2.75 Millimeter
  • Balloon Length: 20 Millimeter
H7493960820270

  • Coronary angioplasty balloon catheter, drug-coated
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