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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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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

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

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

OSSIX™ Bone - 07290015477253

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
0.500 cc
In Commercial Distribution

  • 07290015477253 ()

  • Height: 5 Millimeter
  • Length: 10 Millimeter
  • Depth: 10 Millimeter
  • 0.500 cc
OXB0500

  • Dental bone matrix implant, synthetic

Osseolive Dental - ECURL20M0250

Device Name: Curasan OSSEOLIVE® DENTAL lndications for Use: OSSEOLIVE® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g.: - Defects after the extirpation of bone cysts - Augmentation of an atrophied alveolar ridge - Sinus lift or sinus floor elevation (subantral augmentation) - Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge - Filling of extraction defects to create an implant bed - Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects - Defects after operative removal of retained teeth or corrective osteotomies
curasan AG
250-1000µm
In Commercial Distribution

  • ECURL20M0250 ()
  • ECURL20M02505 ()
5x2.0 cc

  • Dental bone matrix implant, synthetic

TRYPTIK CC INSTRUMENTATION - 07640151081881

Compactor
SpineArt SA
TRY-IN 01 00-N
In Commercial Distribution

  • 07640151081881 ()
TRY-IN 01 00-N

  • Bone graft packing block

TRYPTIK CC INSTRUMENTATION - 07640151081836

Convex Trial D14 H12
SpineArt SA
TRY-IA 14 12-N
In Commercial Distribution

  • 07640151081836 ()
TRY-IA 14 12-N

  • Surgical implant/trial-implant/sizer holder, reusable

TRYPTIK CC INSTRUMENTATION - 07640151081829

Convex Trial D14 H11
SpineArt SA
TRY-IA 14 11-N
In Commercial Distribution

  • 07640151081829 ()
TRY-IA 14 11-N

  • Surgical implant/trial-implant/sizer holder, reusable

TRYPTIK CC INSTRUMENTATION - 07640151081812

Convex Trial D14 H10
SpineArt SA
TRY-IA 14 10-N
In Commercial Distribution

  • 07640151081812 ()
TRY-IA 14 10-N

  • Surgical implant/trial-implant/sizer holder, reusable
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