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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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XiVE® TG Lab Set Implant-/Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32259306
Not in Commercial Distribution

  • EFRI322593062 ()
25-9306

  • Dental implant suprastructure kit
XiVE® TG Lab Set Implant-/Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32259305
Not in Commercial Distribution

  • EFRI322593052 ()
25-9305

  • Dental implant suprastructure kit
XiVE® TG Titanium Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254241
Not in Commercial Distribution

  • EFRI322542412 ()
25-4241

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Gold Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254240
Not in Commercial Distribution

  • EFRI322542402 ()
25-4240

  • Dental implant suprastructure, permanent, preformed
Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
True Indicating LLC
MSCST-05L
In Commercial Distribution

  • 00860011103493 ()
MSCST-05L

  • Biological sterilization indicator
Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
True Indicating LLC
MSCST-05L
In Commercial Distribution

  • 00860011103400 ()
MSCST-05L

  • Biological sterilization indicator
Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)
True Indicating LLC
MSCST-05L
In Commercial Distribution

  • 00860008246745 ()
MSCST-05L

  • Biological sterilization indicator
No Description
W.H. Holden, Inc.
70-6260
In Commercial Distribution

  • D9287062600 ()


  • Dental spatula, reusable
MDRC-2424 HPEW
Barco NV
MDRC-2424
In Commercial Distribution

  • 05415334046191 ()
K9356052A1X

  • Image display unit, colour
MDRC-2424 HTIB
Barco NV
MDRC-2424
In Commercial Distribution

  • 05415334046184 ()
K9356050A1X

  • Image display unit, colour
MDRC-2424 HNEW
Barco NV
MDRC-2424
In Commercial Distribution

  • 05415334046177 ()
K9356051A1X

  • Image display unit, colour
MDRC-2424 STIB
Barco NV
MDRC-2424
In Commercial Distribution

  • 05415334046160 ()
K9356043A1X

  • Image display unit, colour
MDRC-2424 HNIB
Barco NV
MDRC-2424
In Commercial Distribution

  • 05415334046153 ()
K9356042A1X

  • Image display unit, colour
MDRC-2424 SNIB
Barco NV
MDRC-2424
In Commercial Distribution

  • 05415334046030 ()
K9356041A1X

  • Image display unit, colour
MDRC-2424 HTEW
Barco NV
MDRC-2424
In Commercial Distribution

  • 05415334046023 ()
K9356053A1X

  • Image display unit, colour
Triever24 Catheter, 24 Fr, 90 cm, Gen4
INARI MEDICAL INC
22-101
In Commercial Distribution

  • 00850291007185 ()

  • Outer Diameter: 7.6 Millimeter
  • Catheter Working Length: 90 Centimeter


  • Thrombectomy suction catheter
No Description
LIFELINES LIMITED
Amp + BT + WI-FI Kit
In Commercial Distribution

  • 05060275450783 ()
2607

  • Electroencephalograph
No Description
LIFELINES LIMITED
Amp + WI-FI Kit
In Commercial Distribution

  • 05060275450776 ()
2606

  • Electroencephalograph
No Description
LIFELINES LIMITED
Amp + BT Kit
In Commercial Distribution

  • 05060275450769 ()
2605

  • Electroencephalograph
No Description
LIFELINES LIMITED
Amp Kit
In Commercial Distribution

  • 05060275450752 ()
2604

  • Electroencephalograph
No Description
LIFELINES LIMITED
Amp + BT + WI-FI
In Commercial Distribution

  • 05060275450745 ()
1414

  • Electroencephalograph
No Description
LIFELINES LIMITED
Amp + WI-FI
In Commercial Distribution

  • 05060275450738 ()
1413

  • Electroencephalograph
No Description
LIFELINES LIMITED
Amp + BT
In Commercial Distribution

  • 05060275450721 ()
1412

  • Electroencephalograph
No Description
LIFELINES LIMITED
Amp
In Commercial Distribution

  • 05060275450714 ()
1411

  • Electroencephalograph
A combination centrifuge and reader for IH gel cards
Bio-Rad Medical Diagnostics GmbH
001200
In Commercial Distribution

  • 07611969205486 ()
001200

  • Immunohaematology/blood bank analyser IVD, semi-automated
No Description
Sarstedt Aktiengesellschaft & Co.KG
77.578.552
Not in Commercial Distribution

  • 04038917413497 ()
  • 04038917413480 ()
77.578.552

  • 24-hour urine specimen container IVD, preservative
No Description
QUALITY ELECTRODYNAMICS LLC
Q7000183
In Commercial Distribution

  • 00814848020423 ()


  • MRI system coil, radio-frequency
No Description
QUALITY ELECTRODYNAMICS LLC
Q7000184
In Commercial Distribution

  • 00814848020256 ()


  • MRI system coil, radio-frequency
ETOH_01 24
UTAK LABORATORIES, INC.
ETOH I_01 24
In Commercial Distribution

  • B800ETOHI01245 ()
  • B800ETOHI01240 ()

  • Total Volume: 1.25 Milliliter
ETOH I_01 24

  • Multiple-type clinical chemistry analyte profile IVD, control
Percutaneous Endoscopic Gastrostomy Set
COOK INCORPORATED
G31548
Not in Commercial Distribution

  • 00827002315488 ()
PEG-24-PUSH-SSK-S

  • Gastrostomy tube
Jejunal Feeding Set
COOK INCORPORATED
G31503
In Commercial Distribution

  • 00827002315037 ()
PEGJ-12-24-95-S

  • Gastrojejunostomy tube
Percutaneous Endoscopic Gastrostomy Set
COOK INCORPORATED
G22758
In Commercial Distribution

  • 00827002227583 ()
PEG-24-PUSH-I-S

  • Gastrostomy tube
Percutaneous Endoscopic Gastrostomy Set
COOK INCORPORATED
G22757
In Commercial Distribution

  • 00827002227576 ()
PEG-24-PULL-I-S

  • Gastrostomy tube
Jejunal Feeding Set
COOK INCORPORATED
G22760
In Commercial Distribution

  • 00827002227606 ()
PEGJ-12-24-I-S

  • Gastrojejunostomy tube
Jejunal Feeding Set
COOK INCORPORATED
G22639
In Commercial Distribution

  • 00827002226395 ()
PEGJ-12-24-S

  • Gastrojejunostomy tube
Percutaneous Endoscopic Gastrostomy Set
COOK INCORPORATED
G22636
In Commercial Distribution

  • 00827002226364 ()
PEG-24-PULL-S

  • Gastrostomy tube
Percutaneous Endoscopic Gastrostomy Set
COOK INCORPORATED
G22635
In Commercial Distribution

  • 00827002226357 ()
PEG-24-PUSH-S

  • Gastrostomy tube
Gold based noble metal
ARGEN CORPORATION, THE
102396
In Commercial Distribution

  • D818102396 ()
102396

  • Dental casting noble alloy
No Description
DFIX
01
In Commercial Distribution

  • 08800125000068 ()

  • Wound size 20 to 25cm


  • Skin-closing tension device
PEG 24 Percutaneous Endoscopic Gastrostomy Set - Pull
COOK INCORPORATED
G56402
Not in Commercial Distribution

  • 00827002564022 ()
PEG-24-PULL-SSK-S-T

  • Gastrostomy tube
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