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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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The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0729105US
In Commercial Distribution

  • 08592346779709 ()


  • Non-fixed medical gas cylinder regulator
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0729102US
In Commercial Distribution

  • 08592346755550 ()


  • Non-fixed medical gas cylinder regulator
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0729103US
In Commercial Distribution

  • 08592346755512 ()


  • Non-fixed medical gas cylinder regulator
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0729104US
In Commercial Distribution

  • 08592346755505 ()


  • Non-fixed medical gas cylinder regulator
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0729100US
In Commercial Distribution

  • 08592346755376 ()


  • Non-fixed medical gas cylinder regulator
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0729101US
In Commercial Distribution

  • 08592346755369 ()


  • Non-fixed medical gas cylinder regulator
Mediflow devices are intended for the administration of the following medical gases in the treatment and care of patients. This flow selector is intended to be fitted to medical gas pipeline system terminal units in hospitals or ambulance cars or to a quick connector outlet of a medical gas regulator.
GCE, s.r.o.
0730104US
In Commercial Distribution

  • 08592346749436 ()


  • Medical gas flowmeter, Thorpe tube
Mediflow devices are intended for the administration of the following medical gases in the treatment and care of patients. This flow selector is intended to be fitted to medical gas pipeline system terminal units in hospitals or ambulance cars or to a quick connector outlet of a medical gas regulator.
GCE, s.r.o.
0730102US
In Commercial Distribution

  • 08592346749412 ()


  • Medical gas flowmeter, Thorpe tube
Mediflow devices are intended for the administration of the following medical gases in the treatment and care of patients. This flow selector is intended to be fitted to medical gas pipeline system terminal units in hospitals or ambulance cars or to a quick connector outlet of a medical gas regulator.
GCE, s.r.o.
0730101US
In Commercial Distribution

  • 08592346749405 ()


  • Medical gas flowmeter, Thorpe tube
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0728102US
In Commercial Distribution

  • 08592346749399 ()


  • Non-fixed medical gas cylinder regulator
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
GCE, s.r.o.
0728101US
In Commercial Distribution

  • 08592346749382 ()


  • Non-fixed medical gas cylinder regulator
No Description
Medshape, Inc.
2200-19-0020
In Commercial Distribution

  • M97022001900200 ()


  • Orthopaedic bone-fragment manipulator, single-use
STOP H.9 MM FOR DRILL M.I.S.E. EVO KIT
SWEDEN & MARTINA SPA
KM-S-09
In Commercial Distribution

  • D7701022023 ()
KM-S-09

  • Dental implant/prosthesis surgical procedure kit
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
239562
In Commercial Distribution

  • 03661489395628 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
201772
In Commercial Distribution

  • 03661489017728 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
HELENA LABORATORIES CORPORATION
552697
In Commercial Distribution

  • M5255526970 ()


  • Protein electrophoresis IVD, kit, electrophoresis
RUBBER DAM CLAMP (1/pack) Material: Spring tempered stainless steel, Size: 9; For more information: https://www.scottsdental.com/rubber-dam-clamps-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
144-C9
In Commercial Distribution

  • D778144C90 ()
144-C9

  • Rubber dam clamp
The Direct Fluorescent Antibody Reagents are intended for the presumptive (serological) identification of Legionella pneumophila serogroups 2 through 14 from culture isolates.
PRO-LAB, INCORPORATED
PL.278
In Commercial Distribution

  • 10628429001872 ()
PL.278

  • Legionella pneumophila nucleic acid IVD, reagent
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1054
In Commercial Distribution

  • 07640136270132 ()


  • External orthopaedic fixation system, single-use
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1053
In Commercial Distribution

  • 07640136270125 ()


  • External orthopaedic fixation system, single-use
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1052
In Commercial Distribution

  • 07640136270118 ()


  • External orthopaedic fixation system, single-use
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1026
In Commercial Distribution

  • 07640136270040 ()


  • External orthopaedic fixation system, single-use
Oval Pessary is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Oval w/support # 9
In Commercial Distribution

  • M803050119 ()
050119

  • Pelvic-organ-supporting pessary
Cube Pessary is used treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Cube w/drain # 9
In Commercial Distribution

  • M803050075 ()
050075

  • Pelvic-organ-supporting pessary
Pessary ring is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Ring w/support #9
In Commercial Distribution

  • M803050034 ()
050034

  • Pelvic-organ-supporting pessary
No Description
Laborie Medical Technologies Canada ULC
9021P5091
In Commercial Distribution

  • 20627825007102 ()
  • 10627825007105 ()
  • 30627825007109 ()


  • Urodynamic manometric catheter, non-electronic
No Description
Bonebridge AG
B-240100
In Commercial Distribution

  • 07640187462173 ()


  • Orthopaedic fixation plate, non-bioabsorbable
Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07810
In Commercial Distribution

  • 00310866002422 ()
07810

  • Gingival retraction cord, medicated
Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07810
Not in Commercial Distribution

  • 00310866000589 ()
07810

  • Gingival retraction cord, medicated
Untreated Braided Gingival Retraction Cord, 100 inches, Size: 9/1
PASCAL COMPANY, INC.
07410
In Commercial Distribution

  • 00310866000466 ()
07410

  • Gingival retraction cord, non-medicated
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