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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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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 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
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
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
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
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
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 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 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 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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