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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Steam Sterilizer – 533HC-E,L1,SD,380 VPS BRASS,DU,PWR,R+2,REC/TF,380
GETINGE IC PRODUCTION POLAND SP Z O O
533HC
In Commercial Distribution

  • 05902533510634 ()
5SSCUPHRTWAA

  • Steam sterilizer
WillowWood One TF System, Side Mount LLVS 2 with Alpha Duo Liner Kit, Large Plus
Willowwood Global LLC
ONE-TF-SIDE-DUO-3
In Commercial Distribution

  • 00194711301041 ()
ONE-TF-SIDE-DUO-3

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
WillowWood One TF System, Side Mount LLVS 2 with Alpha Duo Liner Kit, Medium Plus
Willowwood Global LLC
ONE-TF-SIDE-DUO-1
In Commercial Distribution

  • 00194711301034 ()
ONE-TF-SIDE-DUO-1

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
WillowWood One TF System, Distal Mount LLVS 2 with Alpha Duo Liner Kit, Large Plus
Willowwood Global LLC
ONE-TF-DISTAL-DUO-3
In Commercial Distribution

  • 00194711300976 ()
ONE-TF-DISTAL-DUO-3

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
WillowWood One TF System, Distal Mount LLVS 2 with Alpha Duo Liner Kit, Medium Plus
Willowwood Global LLC
ONE-TF-DISTAL-DUO-1
In Commercial Distribution

  • 00194711300952 ()
ONE-TF-DISTAL-DUO-1

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
STEAM STERILIZER HC - 533HC-E,L1,SD,EJ-SST,DU,MAN,R+2,REC/TF,380 SST
GETINGE IC PRODUCTION POLAND SP Z O O
533HC
In Commercial Distribution

  • 05902533548828 ()
5SSPUMHRTDAA

  • Steam sterilizer
Airwave Oscillometry System to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Version compatible with ClearFlo PFT filter. Includes power supply, ethernet cable, and user manual.
Thorasys Thoracic Medical Systems Inc
101336
In Commercial Distribution

  • 07540261013362 ()


  • Pulmonary function analysis system, adult
Legend Pro H7X7 DISPOSABLE TIP ASSY 5 PACKED
POLLOGEN LTD
H7X7
In Commercial Distribution

  • 07290016586206 ()
  • 17290016586203 ()
30010140LP

  • Radio-frequency skin contouring system applicator tip
STEAM STERILIZER HC - 533HC-E,L1,DD,EJ-SST,DU,MAN,HC,R+2,REC/TF,380 SST
GETINGE IC PRODUCTION POLAND SP Z O O
533HC
In Commercial Distribution

  • 05902533548835 ()
5SDPUMHRTDAA

  • Steam sterilizer
THERMOFLECT KIT 3, UNIV, 25EA TS TF KIT, BLKT, CAP, FOOTWEAR, BAG, SILVER, 1/BG, 25 BG/CS
Encompass Group, L.L.C.
5200-800
In Commercial Distribution

  • 10612899004303 ()
  • 00612899004306 ()


  • Hypothermia-prevention whole-body suit
The tremoflo C-100 Airwave Oscillometry System & Accessories - Vitalograph US Healthcare Edition is compatible with Vitalograph's Eco BVF with Bit Lip Filter (28553).
Thorasys Thoracic Medical Systems Inc
102181
In Commercial Distribution

  • 07540261021817 ()


  • Pulmonary function analysis system, adult
The tremoflo C2 Sensor Module - Eco BVF is the sensor module for use with tremoflo C2 device model 102237.
Thorasys Thoracic Medical Systems Inc
102233
In Commercial Distribution

  • 07540261022333 ()


  • Pulmonary function analysis system, adult
PATIENT TRANSFER KIT C, 25EA TS PT TRANS KIT, GOWN, TF BLKT, ST SHEET, PC, 1/BG, 25 BG/CS
Encompass Group, L.L.C.
5400-210
In Commercial Distribution

  • 10612899004402 ()
  • 00612899004405 ()


  • Hypothermia-prevention whole-body suit
2 year valid Reference Load (15 cm H2O.s/L) to verify tremoflo Airwave Oscillometry System calibration.
Thorasys Thoracic Medical Systems Inc
102069
In Commercial Distribution

  • 07540261020698 ()


  • Pulmonary function analysis system, adult
The tremoflo C-100 Airwave Oscillometry System and Accessories - Vitalograph Clinical Trial Edition is compatible with Vitalograph's Blue BVP with Bit Lip Filter (28350).
Thorasys Thoracic Medical Systems Inc
101761
In Commercial Distribution

  • 07540261017612 ()


  • Pulmonary function analysis system, adult
PATIENT TRANSFER KIT D, 25EA TS PT TRANS KIT, GOWN TF BLKT ST SHEET PC PILL 1/BG 25 BG/CS
Encompass Group, L.L.C.
5400-230
In Commercial Distribution

  • 50612899286899 ()
  • 00612899286894 ()


  • Hypothermia-prevention whole-body suit
No Description
Bonebridge AG
B-122110
In Commercial Distribution

  • 07640187461343 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Bonebridge AG
B-121110
In Commercial Distribution

  • 07640187461336 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Bonebridge AG
B-122010
In Commercial Distribution

  • 07640187461329 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Bonebridge AG
B-121010
In Commercial Distribution

  • 07640187461312 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
MAR COR PURIFICATION, INC.
RO,S704,TF,60HZ,TALL,WHITE
In Commercial Distribution

  • 00817492020962 ()

  • Weight: 90 Pound
  • Height: 40.5 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S704,TF,60H,SH,WH
In Commercial Distribution

  • 00817492020948 ()

  • Weight: 90 Pound
  • Height: 31 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S704,TF,50H,SH,WH
In Commercial Distribution

  • 00817492020931 ()

  • Weight: 90 Pound
  • Height: 31 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S703,TF,60H,TL,WH
In Commercial Distribution

  • 00817492020924 ()

  • Weight: 80 Pound
  • Height: 40.5 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S703,TF,60H,SH,WH
In Commercial Distribution

  • 00817492020917 ()

  • Weight: 80 Pound
  • Height: 31 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S703,TF,50H,SH,WH
In Commercial Distribution

  • 00817492020900 ()

  • Weight: 80 Pound
  • Height: 31 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S702,TF,60H,TL,WHT
In Commercial Distribution

  • 00817492020894 ()

  • Weight: 70 Pound
  • Height: 40.5 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S702,TF,60H,SH,WH
In Commercial Distribution

  • 00817492020887 ()

  • Weight: 70 Pound
  • Height: 31 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S702,TF,50H,SH,WH
In Commercial Distribution

  • 00817492020870 ()

  • Weight: 70 Pound
  • Height: 31 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S701,TF,60H,TL,WH
In Commercial Distribution

  • 00817492020863 ()

  • Weight: 60 Pound
  • Height: 40.5 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S701,TF,60H,SH,WH
In Commercial Distribution

  • 00817492020856 ()

  • Weight: 60 Pound
  • Height: 31 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
No Description
MAR COR PURIFICATION, INC.
RO,S701,TF,50H,SH,WH
In Commercial Distribution

  • 00817492020849 ()

  • Weight: 60 Pound
  • Height: 31 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
Palodent Plus System Trial Kit
DENTSPLY INTERNATIONAL INC.
659880V
Not in Commercial Distribution

  • D002659880V1 ()

  • 1x Universal Ring, 10x Matrices (5.5mm), 10x Medium Wedges, 10x Medium WedgeGuards, 5x SureFil® SDR® Compula® Tips (Universal shade), 1x Forceps, 1x Pin Tweezers
659880V

  • Dental wedge, single-use
  • Dental matrix band, single-use
  • Rubber dam clamp forceps
  • Dental matrix band tensioner
  • Dental dressing forceps, reusable
Palodent Plus Trial Kit
DENTSPLY INTERNATIONAL INC.
659880
In Commercial Distribution

  • D0026598801 ()

  • 1x Universal Ring, 10x Matrices (5.5mm), 10x Medium Wedges, 10x Medium WedgeGuards, 5x SureFil® SDR® Compula® Tips (Universal shade), 1x Forceps, 1x Pin Tweezers
659880

  • Dental matrix band, single-use
  • Dental wedge, single-use
  • Rubber dam clamp forceps
  • Dental matrix band tensioner
  • Dental dressing forceps, reusable
ANTIFUNGAL QC LEVEL 1
UTAK LABORATORIES, INC.
ANTIF QC 1 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC1V2LPFTF5 ()
  • B800ANTIFQC1V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 1 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGAL QC LEVEL 3
UTAK LABORATORIES, INC.
ANTIF QC 3 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC3V2LPFTF5 ()
  • B800ANTIFQC3V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 3 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGAL QC LEVEL 2
UTAK LABORATORIES, INC.
ANTIF QC 2 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC2V2LPFTF5 ()
  • B800ANTIFQC2V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 2 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
No Description
MAR COR PURIFICATION, INC.
RO,S704,TF,60H,TL,WH,COLD
In Commercial Distribution

  • 00817492020955 ()

  • Weight: 95 Pound
  • Height: 40.5 Inch
  • Depth: 14 Inch
  • Width: 18 Inch


  • Reverse-osmosis water purification system
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