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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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Trabexus ® - 00868201000126

Calcium compound bone void filler (10 cc)
Vivorte, Inc
10 cc
Not in Commercial Distribution

  • 00868201000126 ()
131133-10

  • Bone matrix implant, synthetic, non-antimicrobial

Trabexus ® - 00868201000119

Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000119 ()
131133-05

  • Bone matrix implant, synthetic, non-antimicrobial

Trabexus ® - 00868201000102

Calcium compound bone void filler (3cc)
Vivorte, Inc
3 cc
Not in Commercial Distribution

  • 00868201000102 ()
131133-03

  • Bone matrix implant, synthetic, non-antimicrobial

Corplex P - 00860471002558

Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
1 cc
In Commercial Distribution

  • 00860471002558 ()
CP-0010

  • Collagen wound matrix dressing

Corplex P - 00860471002572

Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
4 cc
In Commercial Distribution

  • 00860471002572 ()
CP-0040

  • Collagen wound matrix dressing

Corplex P - 00860471002565

Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
2 cc
In Commercial Distribution

  • 00860471002565 ()
CP0020

  • Collagen wound matrix dressing

Fortera - 00868201000164

Calcium compound bone void filler (3 cc)
Vivorte, Inc
3 cc
In Commercial Distribution

  • 00868201000164 ()
131133-03-S

  • Bone matrix implant, synthetic, non-antimicrobial

Wizard CaP - 00868201000157

Calcium compound bone void filler (10 cc)
Vivorte, Inc
10 cc
Not in Commercial Distribution

  • 00868201000157 ()


  • Bone matrix implant, synthetic, non-antimicrobial

Wizard CaP - 00868201000140

Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000140 ()


  • Bone matrix implant, synthetic, non-antimicrobial

DOPPLER MODEL 812 IN 901 C/C - 00816787020427

No Description
PARKS MEDICAL ELECTRONICS, INC.
812-1-901 CC
In Commercial Distribution

  • 00816787020427 ()


  • Laser Doppler blood flowmeter

DOPPLER MODEL 812 IN 800 C/C - 00816787020410

No Description
PARKS MEDICAL ELECTRONICS, INC.
812-1-800 CC
In Commercial Distribution

  • 00816787020410 ()


  • Laser Doppler blood flowmeter

Trabexus® - W4146EB0010T0475

Calcium compound bone void filler with DBM (10 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
10 cc
In Commercial Distribution

  • W4146EB0010T0475 ()
130703-10

  • Cadaveric-donor/synthetic mineral bone graft

Trabexus® - W4146EB0005T0475

Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft

Trabexus® - W4146EB0003T0475

Calcium compound bone void filler with DBM (3 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
3 cc
In Commercial Distribution

  • W4146EB0003T0475 ()
130703-03

  • Cadaveric-donor/synthetic mineral bone graft

CONFIDENCE - 03760177046344

No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177046344 ()
183901000

  • Vertebral bone filler, non-bioabsorbable

CONFIDENCE - 03760177043947

No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177043947 ()
183901000

  • Vertebral bone filler, non-bioabsorbable

Progreat Lambda - 04987350741028

Micro Catheter System
TERUMO CLINICAL SUPPLY CO., LTD.
CC*M1916DN
In Commercial Distribution

  • 54987350741023 ()
  • 04987350741028 ()

  • Length: 165 Centimeter
  • Catheter Inner Diameter: 0.48 Millimeter
  • Outer Diameter: 0.64 Millimeter
CCM1916DN

  • Vascular microcatheter

Progreat Lambda - 04987350741004

Micro Catheter System
TERUMO CLINICAL SUPPLY CO., LTD.
CC*M1916AN
In Commercial Distribution

  • 54987350741009 ()
  • 04987350741004 ()

  • Length: 165 Centimeter
  • Catheter Inner Diameter: 0.48 Millimeter
  • Outer Diameter: 0.64 Millimeter
CCM1916AN

  • Vascular microcatheter

Progreat Lambda - 04987350740984

Micro Catheter System
TERUMO CLINICAL SUPPLY CO., LTD.
CC*M1916SN
In Commercial Distribution

  • 04987350740984 ()
  • 54987350740989 ()

  • Length: 165 Centimeter
  • Catheter Inner Diameter: 0.48 Millimeter
  • Outer Diameter: 0.64 Millimeter
CCM1916SN

  • Vascular microcatheter

BELLAFILL - 00350224000141

Bellafill 1.5ml on 1.5cc syringe
SUNEVA MEDICAL, INC.
1.5 cc
In Commercial Distribution

  • 10350224000148 ()
  • 00350224000141 ()
  • 20350224000145 ()
  • 30350224000142 ()
GBF0115, GBF0215, GBF0315

  • Dermal tissue reconstructive material, animal-derived

BELLAFILL - 00350224000028

Bellafill 0.8ml on 1.0cc syringe
SUNEVA MEDICAL, INC.
1.0 cc
In Commercial Distribution

  • 00350224000028 ()
  • 10350224000025 ()
  • 20350224000022 ()
GBF0208, GBF0508

  • Dermal tissue reconstructive material, animal-derived

OssDsign Catalyst - 07350086550733

OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075)
Ossdsign AB
1 cc
In Commercial Distribution

  • 07350086550733 ()
104010

  • Bone matrix implant, synthetic, non-antimicrobial

Gimmi - 04049047694984

MICRO ARTERY CLAMP DOUBLE WITH FRAME ADJUSTABLE, TYPE 3, 1.0 - 2.2 MM LENGTH 16 MM
Gimmi GmbH
CC.1162.10
In Commercial Distribution

  • 04049047694984 ()
CC.1162.10

  • Surgical A/V-shaped microvessel clamp

Gimmi - 04049047694809

MICRO ARTERY CLAMP SINGLE TYPE 5, 2.0 - 5.0 MM LENGTH 36 MM
Gimmi GmbH
CC.1158.20
In Commercial Distribution

  • 04049047694809 ()
CC.1158.20

  • Surgical A/V-shaped microvessel clamp

Gimmi - 04049047694793

MICRO ARTERY CLAMP SINGLE TYPE 4, 1.5 - 3.3 MM LENGTH 24 MM
Gimmi GmbH
CC.1158.15
In Commercial Distribution

  • 04049047694793 ()
CC.1158.15

  • Surgical A/V-shaped microvessel clamp

Gimmi - 04049047694779

MICRO ARTERY CLAMP SINGLE TYPE 2, 0.6 - 1.4 MM LENGTH 11 MM
Gimmi GmbH
CC.1158.06
In Commercial Distribution

  • 04049047694779 ()
CC.1158.06

  • Surgical A/V-shaped microvessel clamp

Gimmi - 04049047694878

MICRO ARTERY CLAMP DOUBLE ADJUSTABLE, TYPE 2, 0.6 - 1.4 MM LENGTH 11 MM
Gimmi GmbH
CC.1160.06
In Commercial Distribution

  • 04049047694878 ()
CC.1160.06

  • Surgical A/V-shaped microvessel clamp

CommunicationConsole - 07090042053044

CommunicationConsole is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. The Communication Console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.
Nordicneurolab AS
CC 2.3
In Commercial Distribution

  • 07090042053044 ()


  • Auditory stimulator

OSSIX™ Bone - 07290015477222

OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked.
DATUM DENTAL LTD
0.250 cc
In Commercial Distribution

  • 07290015477222 ()

  • Height: 5 Millimeter
  • Length: 10 Millimeter
  • Depth: 5 Millimeter
  • 0.250 cc
OXB0250

  • Dental bone matrix implant, synthetic

OSSIX™ Bone - 07290015477215

OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked.
DATUM DENTAL LTD
0.125 cc
In Commercial Distribution

  • 07290015477215 ()

  • 0.125 cc
  • Depth: 5 Millimeter
  • Length: 5 Millimeter
  • Height: 5 Millimeter
OXB0125

  • Dental bone matrix implant, synthetic
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