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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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BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.
Ethicon Inc.
10151
In Commercial Distribution

  • 30705031001118 ()
  • 10705031001114 ()
  • 20705031001111 ()
10151

  • Exudate-absorbent dressing, non-gel, antimicrobial
BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.
Ethicon Inc.
10150
In Commercial Distribution

  • 30705031001101 ()
  • 10705031001107 ()
  • 20705031001104 ()
10150

  • Exudate-absorbent dressing, non-gel, antimicrobial
BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.
Ethicon Inc.
4152
In Commercial Distribution

  • 30705031005253 ()
  • 10705031005259 ()
  • 20705031005256 ()
4152

  • Exudate-absorbent dressing, non-gel, antimicrobial
BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.
Ethicon Inc.
4151
In Commercial Distribution

  • 30705031005246 ()
  • 10705031005242 ()
  • 20705031005249 ()
4151

  • Exudate-absorbent dressing, non-gel, antimicrobial
BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.
Ethicon Inc.
4150
In Commercial Distribution

  • 30705031005239 ()
  • 10705031005235 ()
  • 20705031005232 ()
4150

  • Exudate-absorbent dressing, non-gel, antimicrobial
The StatGuard Hemostatic Dressing is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation. Model 3020-10 provides a 2 cm x 3.5 cm gauze, in an 8 cm x 10 cm adhesive dressing
Semler Technologies, Inc.
3020-20
In Commercial Distribution

  • 10815614020828 ()
  • 20815614020825 ()
  • 30815614020822 ()
480-3020-20

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The StatGuard Hemostatic Dressing is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation. Model 3020-10 provides a 2 cm x 3.5 cm gauze, in a 4 cm x 6 cm adhesive dressing.
Semler Technologies, Inc.
3020-10
In Commercial Distribution

  • 10815614020811 ()
  • 20815614020818 ()
  • 30815614020815 ()
480-3020-10

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Pointe Phencyclidine (PCP) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Phencyclidine (PCP) Reagent Set is intended for the qualitative and semi-quantitative determination of PCP in human urine at a cutoff value of 25 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-PH0020-1L
In Commercial Distribution

  • 00811727016461 ()
60-PH0020-1L

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Pointe Phencyclidine (PCP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Phencyclidine (PCP) Reagent Set is intended for the qualitative and semi-quantitative determination of PCP in human urine at a cutoff value of 25 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-PH0020-100
In Commercial Distribution

  • 00811727016454 ()
60-PH0020-100

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use.
Ascension Orthopedics, Inc.
MGT89040PPT
In Commercial Distribution

  • 10381780119920 ()
  • M268MGT89040PPT1 ()

  • .771 in L x .549 in W x .472 in H; Size 40
MGT89040PPT

  • Partial metatarsophalangeal joint prosthesis
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