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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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FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Link) - 05700571101230

FLEX Monoclonal Mouse Anti-Human Mammaglobin Clone 304-1A5 Ready-to-Use (Link)
AGILENT TECHNOLOGIES, INC.
IR074
In Commercial Distribution

  • 05700571101230 ()

  • 40-60 Tests


  • Mammaglobin IVD, antibody

FLEX Mono Mo A-Hu Podoplanin Cl D2-40 RTU (Link) - 05700571101223

FLEX Monoclonal Mouse Anti-Human Podoplanin Clone D2-40 Ready-to-Use (Link)
AGILENT TECHNOLOGIES, INC.
IR072
In Commercial Distribution

  • 05700571101223 ()

  • 40-60 Tests


  • D2-40 antigen IVD, antibody

FLEX Mono Mo A-Hu CD1a Cl 010 RTU (Link) - 05700571101216

FLEX Monoclonal Mouse Anti-Human CD1a Clone 010 Ready-to-Use (Link)
AGILENT TECHNOLOGIES, INC.
IR069
In Commercial Distribution

  • 05700571101216 ()

  • 40-60 Tests


  • CD1a cell marker IVD, antibody

FLEX Mono Mo A-Myogenin Cl F5D RTU (Link) - 05700571101209

FLEX Monoclonal Mouse Anti-Myogenin Clone F5D Ready-to-Use (Link)
AGILENT TECHNOLOGIES, INC.
IR067
In Commercial Distribution

  • 05700571101209 ()

  • 40-60 Tests


  • Myogenin IVD, antibody

FLEX Mono Mo A-Hu Smooth Muscle Myosin Heavy Chain Cl SMMS-1 RTU (Link) - 05700571101193

FLEX Monoclonal Mouse Anti-Human Smooth Muscle Myosin Heavy Chain Clone SMMS-1 Ready-to-Use (Link)
AGILENT TECHNOLOGIES, INC.
IR066
In Commercial Distribution

  • 05700571101193 ()

  • 40-60 Tests


  • Smooth muscle myosin IVD, antibody

FLEX Poly Guinea Pig A-Insulin RTU (Link) - 05700571101186

FLEX Polyclonal Guinea Pig Anti-Insulin Ready-to-Use (Link)
AGILENT TECHNOLOGIES, INC.
IR002
In Commercial Distribution

  • 05700571101186 ()

  • 40-60 Tests


  • Insulin IVD, antibody

FLEX Mono Mo A-Hu E-Cadherin Cl NCH-38 RTU - 05700571011539

FLEX Monoclonal Mouse Anti-Human E-Cadherin Clone NCH-38 Ready-to-Use (Dako Autostainer/ Autostainer Plus)
AGILENT TECHNOLOGIES, INC.
IS059
Not in Commercial Distribution

  • 05700571011539 ()

  • 20-30 Tests


  • Cadherin protein IVD, antibody

ADVATx - 05700002052209

The laser system is for dermatological indications for use. The laser light is delivered to the patient through an applicator either a scanning hand piece or a single spot hand piece (optional). The ADVATx Laser System consists of a laser cabinet which houses the laser module, the user interface which allows the user to control the system and the laser delivery system. ADVATx does only come in one model. The laser does not use any consumables (besides standard power/electricity), and no accessories are offered. The ADVATx laser system is a Nd:YAG laser delivering 589nm Q-switched pulsed light and 1319nm continuous wave light. This laser has been developed specifically for dermatological (skin) treatments performed by healthcare professionals e.g. doctors.
Advalight ApS
1.0
In Commercial Distribution

  • 05700002052209 ()
  • 05700002052216 ()
684

  • Dermatological frequency-doubled solid-state laser system

Kerecis® Shield® Spiral - 05694310965217

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield® Spiral is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
80 mm Circular
In Commercial Distribution

  • 05694310965224 ()
  • 05694310965217 ()
  • 05694310965231 ()

  • Outer Diameter: 80 Millimeter
50215L54B0D

  • Collagen wound matrix dressing

Kerecis® Shield® Adhesive - 05694310965187

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield® Adhesive is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
15mm Circular
In Commercial Distribution

  • 05694310965194 ()
  • 05694310965187 ()
  • 05694310965200 ()

  • Outer Diameter: 15 Millimeter
50215H50B0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® Silicone - 05694310965163

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-silicone/
KERECIS hf.
10 x 18 cm fish skin
In Commercial Distribution

  • 05694310965170 ()
  • 05694310965163 ()

  • Height: 10 Centimeter
  • Width: 18 Centimeter
50214F56D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® Silicone - 05694310965149

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-silicone/
KERECIS hf.
6 x 14 cm fish skin
In Commercial Distribution

  • 05694310965156 ()
  • 05694310965149 ()

  • Width: 14 Centimeter
  • Height: 6 Centimeter
50214F55D0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Spiral - 05694310964364

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Spiral is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
Diameter: 30mm
In Commercial Distribution

  • 05694310964371 ()
  • 05694310964364 ()

  • Outer Diameter: 30 Millimeter
50215K52B0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Standard - 05694310964319

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Standard is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
Diameter: 50mm
In Commercial Distribution

  • 05694310964326 ()
  • 05694310964319 ()

  • Outer Diameter: 50 Millimeter
50215I53B0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Adhesive - 05694310963770

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Adhesive is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
30 mm Circular
In Commercial Distribution

  • 05694310963787 ()
  • 05694310963770 ()

  • Outer Diameter: 30 Millimeter
50215I52B0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Adhesive - 05694310963756

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Adhesive is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
20 mm Circular
In Commercial Distribution

  • 05694310963763 ()
  • 05694310963756 ()

  • Outer Diameter: 20 Millimeter
50215H51B0D

  • Collagen wound matrix dressing

Halo Systems - 05690977368965

Skull Pin 2-1/4in CT Sterl 6PK
OSSUR AMERICAS, INC.
522CS
Not in Commercial Distribution

  • 05690977368965 ()
522CS

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977368958

Skull Pin 3in TI Sterl 5 PK
OSSUR AMERICAS, INC.
520V2S
Not in Commercial Distribution

  • 05690977368958 ()
520V2S

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977368941

Skull Pin 2-1/4in TI Sterl 5PK
OSSUR AMERICAS, INC.
520TS
Not in Commercial Distribution

  • 05690977368941 ()
520TS

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977368934

Skull Pin 3in TI Sterl 1PK
OSSUR AMERICAS, INC.
516V2S
Not in Commercial Distribution

  • 05690977368934 ()
516V2S

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977343306

CB RING TRAY LG
OSSUR AMERICAS, INC.
555CB
Not in Commercial Distribution

  • 05690977343306 ()
555CB

  • Cervical spine immobilization head ring

Halo Systems - 05690977343283

CB RING TRAY STD
OSSUR AMERICAS, INC.
554CB
Not in Commercial Distribution

  • 05690977343283 ()
554CB

  • Cervical spine immobilization head ring

Halo Systems - 05690977343269

CB RING TRAY SM
OSSUR AMERICAS, INC.
553CB
Not in Commercial Distribution

  • 05690977343269 ()
553CB

  • Cervical spine immobilization head ring

Halo Systems - 05690977334960

CB RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300T
Not in Commercial Distribution

  • 05690977334960 ()
515300T

  • Cervical spine immobilization head ring

Halo Systems - 05690977326200

CB RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500T
Not in Commercial Distribution

  • 05690977326200 ()
515500T

  • Cervical spine immobilization head ring

Halo Systems - 05690977319035

CB RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400T
Not in Commercial Distribution

  • 05690977319035 ()
515400T

  • Cervical spine immobilization head ring

Halo Systems - 05690977309357

Kit Closed Back Halo Lg
OSSUR AMERICAS, INC.
505501C
Not in Commercial Distribution

  • 05690977309357 ()
505501C

  • Cervical spine immobilization head ring

Halo Systems - 05690977309340

Kit Closed Back Halo Sm
OSSUR AMERICAS, INC.
505301C
Not in Commercial Distribution

  • 05690977309340 ()
505301C

  • Cervical spine immobilization head ring

Halo Systems - 05690977309333

Kit Closed Back Halo Md
OSSUR AMERICAS, INC.
505401C
Not in Commercial Distribution

  • 05690977309333 ()
505401C

  • Cervical spine immobilization head ring

Halo Systems - 05690977308695

OB V2 RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500V2
Not in Commercial Distribution

  • 05690977308695 ()
515500V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977308688

OB V2 RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400V2
Not in Commercial Distribution

  • 05690977308688 ()
515400V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977308671

OB V2 RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300V2
Not in Commercial Distribution

  • 05690977308671 ()
515300V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977308664

OB RESOLVE RING KIT LG-No App
OSSUR AMERICAS, INC.
515500D
Not in Commercial Distribution

  • 05690977308664 ()
515500D

  • Cervical spine immobilization head ring

Halo Systems - 05690977308657

OB RESOLVE RING KIT STD-No App
OSSUR AMERICAS, INC.
515400D
Not in Commercial Distribution

  • 05690977308657 ()
515400D

  • Cervical spine immobilization head ring

Halo Systems - 05690977308640

OB RESOLVE RING KIT SM-No App
OSSUR AMERICAS, INC.
515300D
Not in Commercial Distribution

  • 05690977308640 ()
515300D

  • Cervical spine immobilization head ring

Halo Systems - 05690977308633

CB RESOLVE RING KIT LG-No App
OSSUR AMERICAS, INC.
515500C
Not in Commercial Distribution

  • 05690977308633 ()
515500C

  • Cervical spine immobilization head ring

Halo Systems - 05690977308626

CB RESOLVE RING KIT STD-No App
OSSUR AMERICAS, INC.
515400C
Not in Commercial Distribution

  • 05690977308626 ()
515400C

  • Cervical spine immobilization head ring

Halo Systems - 05690977308596

CB RESOLVE RING KIT SM-No App
OSSUR AMERICAS, INC.
515300C
Not in Commercial Distribution

  • 05690977308596 ()
515300C

  • Cervical spine immobilization head ring

Halo Systems - 05690977305908

CB RING KIT TI LG
OSSUR AMERICAS, INC.
505500T
Not in Commercial Distribution

  • 05690977305908 ()
505500T

  • Cervical spine immobilization head ring

Halo Systems - 05690977305892

CB RING KIT TI STD
OSSUR AMERICAS, INC.
505400T
Not in Commercial Distribution

  • 05690977305892 ()
505400T

  • Cervical spine immobilization head ring

Halo Systems - 05690977305885

CB RING KIT TI SM
OSSUR AMERICAS, INC.
505300T
Not in Commercial Distribution

  • 05690977305885 ()
505300T

  • Cervical spine immobilization head ring

Halo Systems - 05690977197404

OB RESOLVE COMPONENT TRAY
OSSUR AMERICAS, INC.
540D
Not in Commercial Distribution

  • 05690977197404 ()
540D

  • Cervical spine immobilization head ring

Halo Systems - 05690977197336

OB RESOLVE STERILE UNIT LGE
OSSUR AMERICAS, INC.
505500D
Not in Commercial Distribution

  • 05690977197336 ()
505500D

  • Cervical spine immobilization head ring

Halo Systems - 05690977197329

OB RESOLVE STERILE UNIT STD
OSSUR AMERICAS, INC.
505400D
Not in Commercial Distribution

  • 05690977197329 ()
505400D

  • Cervical spine immobilization head ring

Halo Systems - 05690977197312

OB RESOLVE STERILE UNIT SML
OSSUR AMERICAS, INC.
505300D
Not in Commercial Distribution

  • 05690977197312 ()
505300D

  • Cervical spine immobilization head ring

Halo Systems - 05690977196636

HALO APPLICATION TRAY
OSSUR AMERICAS, INC.
538
Not in Commercial Distribution

  • 05690977196636 ()
538

  • Cervical spine immobilization head ring

Halo Systems - 05690977194090

Skull Pin 2-1/4in CT Sterl 1PK
OSSUR AMERICAS, INC.
516CS
Not in Commercial Distribution

  • 05690977194090 ()
516CS

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977192577

Skull Pin 3in CT Sterl 4 PK
OSSUR AMERICAS, INC.
517DS
Not in Commercial Distribution

  • 05690977192577 ()
517DS

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977192348

STERILE V2 COMPONENT TRAY
OSSUR AMERICAS, INC.
540V2
Not in Commercial Distribution

  • 05690977192348 ()
540V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977165335

RESOLVE HALO COMP TRAY
OSSUR AMERICAS, INC.
540C
Not in Commercial Distribution

  • 05690977165335 ()
540C

  • Cervical spine immobilization head ring
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