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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Fix mount drencher shower head, chrome
WATER PIK, INC.
XMT-633E
Not in Commercial Distribution

  • 00073950259033 ()
XMT-633E

  • External manual massager, home-use
Hand held shower head, chrome
WATER PIK, INC.
LBT-563M
Not in Commercial Distribution

  • 00073950254137 ()
LBT-563M

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

  • 00073950247979 ()
XMD-639E

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

  • 00073950236119 ()
XMT-639

  • External manual massager, home-use
Weight scale with wireless communication - Bluetooth
Omron Healthcare, Inc.
SC-150
In Commercial Distribution

  • 10073796931503 ()
  • 00073796931506 ()
SC-150

  • Stand-on floor scale, electronic
PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PSDA45GIATHN
In Commercial Distribution

  • 50085412658839 ()
  • 00085412658834 ()

  • Length: 45 Millimeter
PSDA45GIATHN

  • Staple line-reinforcement strip
PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PSDA45GIA
In Commercial Distribution

  • 50085412658686 ()
  • 00085412658681 ()

  • Length: 45 Millimeter
PSDA45GIA

  • Staple line-reinforcement strip
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
Femur with Aurum, size 7
TOTAL JOINT ORTHOPEDICS, INC.
5104.07.000
In Commercial Distribution

  • 00814703017100 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 6
TOTAL JOINT ORTHOPEDICS, INC.
5104.06.000
In Commercial Distribution

  • 00814703017094 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 5
TOTAL JOINT ORTHOPEDICS, INC.
5104.05.000
In Commercial Distribution

  • 00814703017087 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 4
TOTAL JOINT ORTHOPEDICS, INC.
5104.04.000
In Commercial Distribution

  • 00814703017070 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 3
TOTAL JOINT ORTHOPEDICS, INC.
5104.03.000
In Commercial Distribution

  • 00814703017063 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 2
TOTAL JOINT ORTHOPEDICS, INC.
5104.02.000
In Commercial Distribution

  • 00814703017056 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 1
TOTAL JOINT ORTHOPEDICS, INC.
5104.01.000
In Commercial Distribution

  • 00814703017049 ()


  • Uncoated knee femur prosthesis, metallic
AnchorSeed/TSL in FlatPack – 15 stranded seeds per mag– STERILE
THERAGENICS CORPORATION
XX77315F
In Commercial Distribution

  • 00813787021317 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed/TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77315N
In Commercial Distribution

  • 00813787021300 ()


  • Manual brachytherapy source, permanent implant
Loose VariStrand with 1-9 seeds, standard spacing
THERAGENICS CORPORATION
XX772xL
In Commercial Distribution

  • 00813787021256 ()


  • Manual brachytherapy source, permanent implant
Loose VariStrand with 1-9 seeds, standard spacing
THERAGENICS CORPORATION
XX772xiL
In Commercial Distribution

  • 00813787021249 ()


  • Manual brachytherapy source, permanent implant
VariStrand with x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX772x
In Commercial Distribution

  • 00813787021188 ()


  • Manual brachytherapy source, permanent implant
AnchorLoad with x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX782x
In Commercial Distribution

  • 00813787021164 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed in Flatpack – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215F
In Commercial Distribution

  • 00813787021140 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215N
In Commercial Distribution

  • 00813787021126 ()


  • Manual brachytherapy source, permanent implant
TheraSleeve with x = 1-20 seeds and 0 or more spacers for CN
THERAGENICS CORPORATION
XX92xi
Not in Commercial Distribution

  • 00813787020495 ()


  • Manual brachytherapy source, permanent implant
TheraLoad with x = 1-20 seeds and 0 or more spacers for CN
THERAGENICS CORPORATION
XX82xi
Not in Commercial Distribution

  • 00813787020471 ()


  • Manual brachytherapy source, permanent implant
TheraStrand with x = 1-12 seeds and 0 or more spacers for CN
THERAGENICS CORPORATION
XX72xi
Not in Commercial Distribution

  • 00813787020464 ()


  • Manual brachytherapy source, permanent implant
Loose TheraStrand® with 1-6 seeds, standard spacing, in TPSII Ind. for CN
THERAGENICS CORPORATION
XX72xiLN
Not in Commercial Distribution

  • 00813787020457 ()


  • Manual brachytherapy source, permanent implant
Loose TheraStrand® with 1-6 seeds, standard spacing for CN
THERAGENICS CORPORATION
XX72xiL
Not in Commercial Distribution

  • 00813787020440 ()


  • Manual brachytherapy source, permanent implant
TheraSleeve with x = 1-12 seeds and 0 or more markers
THERAGENICS CORPORATION
XX992xi
In Commercial Distribution

  • 00813787020433 ()


  • Manual brachytherapy source, permanent implant
TheraSleeve with x = 1-20 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX92xi
In Commercial Distribution

  • 00813787020419 ()


  • Manual brachytherapy source, permanent implant
TheraLoad with x = 1-20 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX82xi
In Commercial Distribution

  • 00813787020396 ()


  • Manual brachytherapy source, permanent implant
TheraStrand with 10 seeds and 0 or spacers in Mesh
THERAGENICS CORPORATION
XX7210iSM
In Commercial Distribution

  • 00813787020389 ()


  • Manual brachytherapy source, permanent implant
TheraStrand® with x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX72xi
In Commercial Distribution

  • 00813787020372 ()


  • Manual brachytherapy source, permanent implant
Loose TheraStrand® with 1-6 seeds, standard spacing, in TPSII Ind.
THERAGENICS CORPORATION
XX72xiLN
In Commercial Distribution

  • 00813787020365 ()


  • Manual brachytherapy source, permanent implant
Loose TheraStrand® with 1-6 seeds, standard spacing
THERAGENICS CORPORATION
XX72xiL
In Commercial Distribution

  • 00813787020358 ()


  • Manual brachytherapy source, permanent implant
TheraStrand® TSL in Flatpack – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215iF
In Commercial Distribution

  • 00813787020327 ()


  • Manual brachytherapy source, permanent implant
TheraStrand® TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215iN
In Commercial Distribution

  • 00813787020310 ()


  • Manual brachytherapy source, permanent implant
TheraStrand® TSL in TPSII Single – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215i
In Commercial Distribution

  • 00813787020303 ()


  • Manual brachytherapy source, permanent implant
No Description
Avante
6G001CO2
In Commercial Distribution

  • 00815871022774 ()


  • General-purpose multi-parameter bedside monitor
CGA-870 WITH D OXYGEN CYLINDER
INOVO, INC.
CYLDTFV
Not in Commercial Distribution

  • 00814470020471 ()


  • Non-fixed medical gas cylinder regulator
CGA-870 WITH M9 OXYGEN CYLINDER
INOVO, INC.
CYLM9TFV
Not in Commercial Distribution

  • 00814470020464 ()


  • Non-fixed medical gas cylinder regulator
CGA-870 WITH M6 OXYGEN CYLINDER
INOVO, INC.
CYLM6TFV
Not in Commercial Distribution

  • 00814470020457 ()


  • Non-fixed medical gas cylinder regulator
CGA-870 WITH ML6 OXYGEN CYLINDER
INOVO, INC.
CYLML6TFV
Not in Commercial Distribution

  • 00814470020440 ()


  • Non-fixed medical gas cylinder regulator
Dermatocope with polarized filter
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-313
Not in Commercial Distribution

  • B1623131 ()
FEDMEDICFIUVWP_US

  • Otoscope, direct
AEROBIKA OPEP with Manometer
Trudell Medical International
110504
In Commercial Distribution

  • 10762860105048 ()
  • 00762860105041 ()
  • 62860110504023 ()


  • Positive pressure airway secretion-clearing device
RESPICHAMBER™ VHC with Mouthpiece
Trudell Medical International
101533
In Commercial Distribution

  • 10762860001135 ()
  • 00762860001138 ()


  • Medicine chamber spacer, reusable
Vessel Dilator with Collar 8F
ARGON MEDICAL DEVICES, INC.
392413
Not in Commercial Distribution

  • 10886333210548 ()
  • 00886333210541 ()

  • 8 French
392413

  • Fascial tissue dilator, single-use
Vessel Dilator with Collar 7 French
ARGON MEDICAL DEVICES, INC.
392412
Not in Commercial Distribution

  • 10886333210531 ()
  • 00886333210534 ()

  • 7 French
392412

  • Fascial tissue dilator, single-use
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