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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No Description
Safecare Biotech (Hangzhou) Co., Ltd.
7 tests
In Commercial Distribution

  • 06974246461304 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
7 tests
In Commercial Distribution

  • 06974246461274 ()
MDP-1074

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
7 tests
In Commercial Distribution

  • 06974246461236 ()
MDP-1054

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
7 Tests
In Commercial Distribution

  • 06974246461649 ()
PH-6012

  • Vaginal pH screening IVD, kit, rapid colorimetric, clinical
No Description
TENS PLUS INDUSTRIAL COMPANY
Hand.P.7
In Commercial Distribution

  • 14897076721754 ()


  • Moxa
Vasoview 7 XB, OUS
MAQUET CARDIOVASCULAR LLC
VH-3200-W
In Commercial Distribution

  • 00607567700437 ()
VH-3200-W

  • Flexible endoscopic scissors, reusable
Reusable Surgical Tool
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
50156
In Commercial Distribution

  • 09008738501562 ()
10763-003

  • Skin flap thickness gauge
Nemoto DUAL SHOT alpha 7 contrast delivery system for CT applications.
NEMOTO KYORINDO CO.,LTD.
170
In Commercial Distribution

  • 04560138481707 ()
  • 14560138481704 ()


  • CT contrast medium injection system, line-powered, mobile
N/A
COCHLEAR LIMITED
Z544583
In Commercial Distribution

  • 09321502036214 ()
  • 09321502041638 ()
Z544583

  • Cochlear implant system waterproof kit
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S0004
In Commercial Distribution

  • 00849405011408 ()


  • Negative-pressure wound therapy system, electric, single-use
No Description
W.H. Holden, Inc.
70-6210-1
In Commercial Distribution

  • D92870621010 ()


  • Dental mirror, reusable
No Description
W.H. Holden, Inc.
70-6210
In Commercial Distribution

  • D9287062100 ()


  • Dental mirror, reusable
No Description
W.H. Holden, Inc.
13-0009
In Commercial Distribution

  • D9281300090 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
No Description
W.H. Holden, Inc.
11-0064
In Commercial Distribution

  • D9281100640 ()


  • Dental surgical scissors
No Description
W.H. Holden, Inc.
11-0063
In Commercial Distribution

  • D9281100630 ()


  • Dental surgical scissors
No Description
W.H. Holden, Inc.
11-0047-1
In Commercial Distribution

  • D92811004710 ()


  • Dental surgical scissors
No Description
BIOCARE MEDICAL LLC
PFA7185V
In Commercial Distribution

  • 00847627000538 ()


  • Nucleic acid hybridization detection IVD, probe
No Description
BIOCARE MEDICAL LLC
PFA7184V
In Commercial Distribution

  • 00847627000521 ()


  • Nucleic acid hybridization detection IVD, probe
No Description
BIOCARE MEDICAL LLC
CFA7188Y
In Commercial Distribution

  • 00847627000194 ()


  • Nucleic acid hybridization detection IVD, probe
No Description
BIOCARE MEDICAL LLC
CFA7187A
In Commercial Distribution

  • 00847627000187 ()


  • Nucleic acid hybridization detection IVD, probe
No Description
JEOL LTD.
781611423
In Commercial Distribution

  • 04987762129827 ()
  • 14987762129824 ()


  • Multiple clinical chemistry enzyme IVD, control
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-507
In Commercial Distribution

  • 09348215073558 ()


  • Surgical implant template, reusable
Conformity stem, collared, #7
UNITED ORTHOPEDIC CORP.
1110-1007
In Commercial Distribution

  • 04711605583008 ()
1110-1007

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular
No Description
Silipos Holding LLC
13375
In Commercial Distribution

  • 00614464133756 ()


  • External limb prosthesis socket liner
TUBING 7 REINFORCED SAFLO
Canadian Hospital Specialties Limited
014E4002
In Commercial Distribution

  • 50628725097836 ()
  • 00628725097831 ()
014E4002

  • Vacuum hose
Rigid Shield 7 cm
Icad, Inc.
710710
In Commercial Distribution

  • 00858012005403 ()
F5350-7

  • Radiation shielding apron
Tenzing 7 Delivery Catheter
ROUTE 92 MEDICAL
Gen 1
In Commercial Distribution

  • 00853799007541 ()


  • Vascular microcatheter
  • Thrombectomy suction catheter
  • Vascular guide-catheter, single-use
Tenzing 7 Delivery Catheter; Contains Tenzing 7 Delivery Catheter (00853799007541)
ROUTE 92 MEDICAL
Gen 1
In Commercial Distribution

  • 00853799007534 ()
REF 1005

  • Vascular microcatheter
Tenzing 7 Delivery Catheter
ROUTE 92 MEDICAL
Gen 1
Not in Commercial Distribution

  • 00853799007237 ()
REF 1005

  • Vascular microcatheter
No Description
JACE MEDICAL, LLC
115.501.07
Not in Commercial Distribution

  • 00853190008024 ()


  • Orthopaedic fixation plate, non-bioabsorbable
The Global Reference Module 7 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 7
In Commercial Distribution

  • 00850011306574 ()
31-0604-0049

  • Electroencephalographic signal amplifier
No Description
Hasa Optix
HA-SET007
In Commercial Distribution

  • 05404027446578 ()
  • 05404027444550 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00007
In Commercial Distribution

  • 00858395006059 ()
  • 00858395006127 ()
GW-MOL-SP07

  • Dental delivery system instrument unit, electric
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00007
In Commercial Distribution

  • 00858395006394 ()
  • 00858395006127 ()
GW-MOL-SP07

  • Dental delivery system instrument unit, electric
ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 60 TESTS OF 7 INDIVIDUAL ANITGENS
THERA-TEST LABORATORIES, INC
102-005
In Commercial Distribution

  • 00854473003088 ()
102-005

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA)
  • SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
  • SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
  • Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
  • Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)
  • Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
  • Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA)
HEPRO.US Surgical Gloves - Surgical Gloves 1 Case of 10 Boxes - 50 pairs per Box Size 7" Packaging 1 pair per paper bag 50 pairs per box 10 boxes per case Total 500 pairs/Case
HEPRO.US INC.
CT - Surgical Latex Gloves 7"
In Commercial Distribution

  • 00854427007384 ()
  • 85442700738402 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578237 ()
  • 00850014578077 ()
401874-220-7

  • Scintillation-counter radiation survey meter
SET of different CA & HP supplied for students.
Bien-Air Dental SA
1700796-0
In Commercial Distribution

  • J007170079601 ()
1700796-0

  • Surgical power tool system control unit, line-powered
SET of different CA & HP supplied for students.
Bien-Air Dental SA
1700796-001
In Commercial Distribution

  • J00717007960011 ()
1700796-001

  • Dental power tool system handpiece, remotely-driven
No Description
Coltène/Whaledent AG
60020100
In Commercial Distribution

  • J006600201000 ()
60020100

  • Dentine bonding agent/set
No Description
Coltène/Whaledent AG
60019691
Not in Commercial Distribution

  • J006600196910 ()
60019691

  • Dentine bonding agent/set
No Description
Coltène/Whaledent AG
60019690
Not in Commercial Distribution

  • J006600196900 ()
60019690

  • Dentine bonding agent/set
No Description
Coltène/Whaledent AG
60019541
In Commercial Distribution

  • J006600195410 ()
60019541

  • Dentine bonding agent/set
No Description
Coltène/Whaledent AG
60019540
In Commercial Distribution

  • J006600195400 ()
60019540

  • Dentine bonding agent/set
No Description
Coltène/Whaledent AG
60019539
In Commercial Distribution

  • J006600195390 ()
60019539

  • Dentine bonding agent/set
No Description
Coltène/Whaledent AG
60019538
In Commercial Distribution

  • J006600195380 ()
60019538

  • Dentine bonding agent/set
No Description
Biomet Orthopedics, LLC
35-352348
In Commercial Distribution

  • 00880304359710 ()

  • .045 (D) X 9 (L) S/S
35-352348

  • Orthopaedic bone wire
No Description
Roche Diagnostics GmbH
11008552160
In Commercial Distribution

  • 00075537671603 ()
11008552160

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-15
In Commercial Distribution

  • 00817830022665 ()

  • Length: 75 Millimeter
07RD-7070-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / PCP / THC
RAPID DIAGNOSTICS INC
07RD7070-08
In Commercial Distribution

  • 00817830022078 ()

  • Length: 75 Millimeter
07RD7070-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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