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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The NeoShades are indicated for use as eye protection during phototherapy sessions. They are intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Micro Plain
In Commercial Distribution

  • 00812594013102 ()
  • 10812594013109 ()
N720PL

  • Eye mask
The NeoShades are indicated for use as eye protection during phototherapy sessions. They are intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Micro
In Commercial Distribution

  • 00812594010873 ()
  • 10812594010870 ()
N727

  • Eye mask
Cross Bar with Clamp Assembly
KOROS U.S.A., INC.
8760-20
In Commercial Distribution

  • 00840199536634 ()
  • 10840199536631 ()

  • 9x12mm
8760-20

  • Self-retaining surgical retractor, reusable
Neuromonitoring Wire with Clip
KOROS U.S.A., INC.
7332-89D
In Commercial Distribution

  • 10840199500052 ()

  • 3m long
7332-89D

  • Nerve-locating system probe, single-use
30cm Cannula with Guide
ATRICURE, INC.
CSK-6130
In Commercial Distribution

  • 30840143903810 ()
  • 10840143904547 ()
  • 50840143903357 ()

  • Length: 30 Centimeter
CSK-6130-3

  • Cardiac radio-frequency ablation system generator
40cm Cannula with Guide
ATRICURE, INC.
CSK-6140
In Commercial Distribution

  • 30840143900314 ()
  • 10840143900303 ()
  • 50840143900233 ()
  • 00818354015393 ()

  • Length: 40 Centimeter


  • Cardiac radio-frequency ablation system generator
30cm Cannula with Guide
ATRICURE, INC.
CSK-6130
In Commercial Distribution

  • 30840143900291 ()
  • 10840143900280 ()
  • 50840143900219 ()
  • 00818354015379 ()

  • Length: 30 Centimeter


  • Cardiac radio-frequency ablation system generator
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 with rotation
In Commercial Distribution

  • 08800018420706 ()


  • X-ray film cassette holder
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
397300bs
In Commercial Distribution

  • 10818674026335 ()
397300bs

  • Suturing unit, reusable
Flex Arm with Clamp
KOROS U.S.A., INC.
7332-98
In Commercial Distribution

  • 00840199516308 ()
  • 10840199516305 ()

  • 9x12mm
7332-98

  • Surgical retraction system, reusable
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
250851
In Commercial Distribution

  • 03661489508516 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Wave Electrode, 60 Hz with accessories - cable length 100 cm
BIONIT LABS SRL
AE02-60
In Commercial Distribution

  • 08057971592876 ()


  • Myoelectric hand prosthesis
Wave Electrode, 60 Hz with accessories - cable length 60 cm
BIONIT LABS SRL
AE02-60
In Commercial Distribution

  • 08057971590971 ()


  • Myoelectric hand prosthesis
Wave Electrode, 60 Hz with accessories - cable length 30 cm
BIONIT LABS SRL
AE02-60
In Commercial Distribution

  • 08057971590964 ()


  • Myoelectric hand prosthesis
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
208644
In Commercial Distribution

  • 03661489086441 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
206964
In Commercial Distribution

  • 03661489069642 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compressed oxygen.
D R BURTON HEALTHCARE, LLC
1
In Commercial Distribution

  • 30851232007722 ()
  • 10851232007728 ()
538

  • Incentive spirometer
Laparoscopic Smoke Filtration System
ARMM INC.
301-S400
In Commercial Distribution

  • 10850082007094 ()
  • 00850082007097 ()


  • Laparoscopic plume filter
This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.
BAXTER HEALTHCARE CORPORATION
5C4466P
In Commercial Distribution

  • 50085412007699 ()
  • 00085412007694 ()
5C4466P

  • Peritoneal dialysis system tubing set
MectaCem-X HV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X HV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
TECRES SPA
65.01.111US
In Commercial Distribution

  • 08031497002163 ()


  • Orthopaedic cement, antimicrobial
MectaCem-X LV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
TECRES SPA
65.01.113US
In Commercial Distribution

  • 08031497002149 ()


  • Orthopaedic cement, antimicrobial
HTF Medium with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90125-500mL
In Commercial Distribution

  • 00893727002910 ()

  • Total Volume: 500 Milliliter
90125

  • IVF medium
HTF Medium with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90125-100mL
In Commercial Distribution

  • 00893727002804 ()

  • Total Volume: 100 Milliliter
90125

  • IVF medium
Fix mount drencher shower head, chrome
WATER PIK, INC.
YPW-833E
In Commercial Distribution

  • 00073950333924 ()
YPW-833E

  • External manual massager, home-use
Hand held shower head, brushed nickel
WATER PIK, INC.
QMR-869ME
In Commercial Distribution

  • 00073950333726 ()
QMR-869ME

  • External manual massager, home-use
Hand held shower head, chrome
WATER PIK, INC.
QMR-863ME
In Commercial Distribution

  • 00073950333689 ()
QMR-863ME

  • External manual massager, home-use
Fix mount drencher shower head, chrome
WATER PIK, INC.
XED-633E
In Commercial Distribution

  • 00073950332996 ()
XED-633E

  • External manual massager, home-use
Hand held shower head, chrome
WATER PIK, INC.
QMR-863ME
In Commercial Distribution

  • 00073950328067 ()
QMR-863ME

  • External manual massager, home-use
Hand held shower head with PowerPulse, white
WATER PIK, INC.
QBS-561MEB
In Commercial Distribution

  • 00073950326896 ()
QBS-561MEB

  • External manual massager, home-use
Hand held shower head, black
WATER PIK, INC.
XOD-765ME
In Commercial Distribution

  • 00073950325219 ()
XOD-765ME

  • External manual massager, home-use
Hand held shower head with PowerPulse, chrome
WATER PIK, INC.
QBS-563MEB
In Commercial Distribution

  • 00073950323154 ()
QBS-563MEB

  • External manual massager, home-use
Hand held shower head with PowerComb and EasySelect, chrome
WATER PIK, INC.
ULZ-563ME
Not in Commercial Distribution

  • 00073950318655 ()
ULZ-563ME

  • External manual massager, home-use
Hand held shower head with DualDock, chrome
WATER PIK, INC.
XOM-763ME
In Commercial Distribution

  • 00073950316392 ()
XOM-763ME

  • External manual massager, home-use
Hand held shower head with PowerComb, chrome
WATER PIK, INC.
XPC-763MVB
In Commercial Distribution

  • 00073950313766 ()
XPC-763MVB

  • External manual massager, home-use
Hand held shower head with multi-height docking and EasySelect, brushed nickel
WATER PIK, INC.
VOD-769MVB
Not in Commercial Distribution

  • 00073950313742 ()
VOD-769MVB

  • External manual massager, home-use
Hand held shower head with DualDock, chrome
WATER PIK, INC.
XOD-763ME
In Commercial Distribution

  • 00073950308977 ()
XOD-763ME

  • External manual massager, home-use
Fix mount drencher shower head, chrome
WATER PIK, INC.
XED-633E
In Commercial Distribution

  • 00073950307949 ()
XED-633E

  • External manual massager, home-use
Hand held shower head with PowerComb, brushed nickel
WATER PIK, INC.
XPC-769ME
In Commercial Distribution

  • 00073950307703 ()
XPC-769ME

  • External manual massager, home-use
Hand held shower head with PowerComb, chrome
WATER PIK, INC.
XPC-763M
In Commercial Distribution

  • 00073950301084 ()
XPC-763M

  • External manual massager, home-use
Hand held shower head, black
WATER PIK, INC.
QTL-965MEP
In Commercial Distribution

  • 00073950300506 ()
QTL-965MEP

  • External manual massager, home-use
Hand held shower head, brushed nickel
WATER PIK, INC.
QTL-969MEP
In Commercial Distribution

  • 00073950299695 ()
QTL-969MEP

  • External manual massager, home-use
Hand held shower head, brushed nickel
WATER PIK, INC.
QTL-969MEP
Not in Commercial Distribution

  • 00073950293440 ()
QTL-969MEP

  • External manual massager, home-use
Fix mount drencher shower head, chrome
WATER PIK, INC.
XMT-633
Not in Commercial Distribution

  • 00073950289504 ()
XMT-633

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XED-639E
In Commercial Distribution

  • 00073950283649 ()
XED-639E

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XED-639E
In Commercial Distribution

  • 00073950279659 ()
XED-639E

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XED-639
Not in Commercial Distribution

  • 00073950273725 ()
XED-639

  • External manual massager, home-use
Fix mount drencher shower head, chrome
WATER PIK, INC.
XED-633
Not in Commercial Distribution

  • 00073950273718 ()
XED-633

  • External manual massager, home-use
Hand held shower head, brushed nickel
WATER PIK, INC.
VOT-669E
Not in Commercial Distribution

  • 00073950272407 ()
VOT-669E

  • External manual massager, home-use
Hand held shower head, chrome
WATER PIK, INC.
VOT-663E
Not in Commercial Distribution

  • 00073950272322 ()
VOT-663E

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XEM-639E
In Commercial Distribution

  • 00073950272209 ()
XEM-639E

  • External manual massager, home-use
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