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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® - 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

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

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

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 - 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

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

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

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

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

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

  • Animal-derived 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

  • Animal-derived wound matrix dressing

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

  • Animal-derived wound matrix dressing

Allacor P - 00850039927362

Allacor 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, 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

  • 00850039927362 ()
AP-0040

  • Animal-derived wound matrix dressing

Allacor P - 00850039927355

Allacor 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, 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

  • 00850039927355 ()
AP-0020

  • Animal-derived wound matrix dressing

Allacor P - 00850039927348

Allacor 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, Allacor 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

  • 00850039927348 ()
AP-0010

  • Animal-derived wound matrix dressing

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

RNA - 10851290002444

CC527 Multi-Level Carton
Rna Medical Division
CC527 Multi-Level
In Commercial Distribution

  • 10851290002444 ()
CC 527

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

RNA - 10851290002437

CC527 Level 3 carton
Rna Medical Division
CC527 Level 3
In Commercial Distribution

  • 10851290002437 ()
CC 527-3

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

RNA - 10851290002420

CC527 Level 2 Carton
Rna Medical Division
CC527 Level 2
In Commercial Distribution

  • 10851290002420 ()
CC 527-2

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

RNA - 10851290002413

CC527 Level 1 Carton
Rna Medical Division
CC527 Level 1
In Commercial Distribution

  • 10851290002413 ()
CC 527-1

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

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

d-Nav® - 00860001044218

Hygieia d-Nav System Phone App - Android Operating System
HYGIEIA, INC.
V1m00b053d
In Commercial Distribution

  • 00860001044218 ()


  • Calculator, programmable

DreamMapper - 00606959054233

DreamMapper Mobile App Android, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054233 ()
1128265

  • Self-care monitoring/reporting software

Beurer - 00850003500430

Ovy by Beurer Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT20
In Commercial Distribution

  • 20850003500434 ()
  • 10850003500437 ()
  • 00850003500430 ()
790.70

  • Thermometric fertility analyser

Sklar - 10649111346149

WIRE SPEC TEMP APP NASAL SD 2 INCHES
SKLAR CORPORATION
22-8824
In Commercial Distribution

  • 10649111346149 ()


  • Eyelid speculum, reusable

ASSURE Patient Application - 00840241600283

ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80601-001
In Commercial Distribution

80601-001

  • Medical equipment clinical data interfacing software

ASSURE Patient Application - 00840241600252

ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80429-003
In Commercial Distribution

80429-003

  • Medical equipment clinical data interfacing software

Panacea - 00092237623824

DS Panacea APP Adj Pump & Deluxe Single Pad
COMPASS HEALTH BRANDS CORP.
DS-APP1-SYS
In Commercial Distribution

  • 30092237623825 ()
  • 00092237623824 ()


  • Alternating-pressure bed mattress overlay system

Irregular Rhythm Notification feature 2.0 - 00194252456774

Irregular Rhythm Notification feature Watch App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00194252456774 ()


  • Self-care monitoring/reporting software

Irregular Rhythm Notification feature 2.0 - 00194252456781

Irregular Rhythm Notification feature iPhone App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00194252456781 ()


  • Self-care monitoring/reporting software

Medicon - 04046826203382

Lathbury cotton app 6" serr tip l/m
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.60
In Commercial Distribution

  • 04046826203382 ()
955.62.60

  • Surgical tamp, reusable

N/A - 00763000287290

SW APP A72200 SCS PATIENT NG PAIN PC
MEDTRONIC, INC.
A72200
In Commercial Distribution

  • 00763000287290 ()


  • Multiple active implantable device programmer

N/A - 00763000371470

SW APP A72400 SCS CLINICIAN PP NG RC
MEDTRONIC, INC.
A72400
In Commercial Distribution

  • 00763000371470 ()


  • Multiple active implantable device programmer

N/A - 00763000371463

SW APP A71400 SCS CLINICIAN CP NG RC
MEDTRONIC, INC.
A71400
In Commercial Distribution

  • 00763000371463 ()


  • Multiple active implantable device programmer

N/A - 00763000520083

SW APP A71200 SCS CLINICIAN NG PAIN PC
MEDTRONIC, INC.
A71200
In Commercial Distribution

  • 00763000520083 ()


  • Multiple active implantable device programmer

NA - 00763000970079

SW APP A52200 GU PATIENT MICRO EU MDR
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000970079 ()


  • Multiple active implantable device programmer

NA - 00763000970062

SW APP A51200 GU CLINICIAN MICRO EU MDR
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000970062 ()


  • Multiple active implantable device programmer

NA - 00763000632793

SW APP A820 TDD PATIENT PROG V2.X
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00763000632793 ()


  • Infusion pump programmer

NA - 00763000632786

SW APP A810 TDD CLINICIAN PROG V2.X
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00763000632786 ()


  • Infusion pump programmer

Diatro•Hypoclean CC - 05999883586631

Diatro•Hypoclean CC hypochlorite cleaning concentrate is a stabilized and micro-filtered concentrated hypochlorite solution for intensive oxidative cleaning, rinsing and washing of hematology analyzers’ capillaries, tubing and chambers, removing blood component precipitates and lipoprotein deposits on all hematology analyzers.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
D801
In Commercial Distribution

  • 15999883586638 ()
  • 05999883586631 ()

  • Total Volume: 100 Milliliter
D8011

  • Wash/cleaning solution IVD, automated/semi-automated system

MacroPor-Si+ 8.0 cc - 00813909013206

Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2508SX
In Commercial Distribution

  • 00813909013206 ()

  • 8.0cc
NB2508SX

  • Bone matrix implant, synthetic, non-antimicrobial

CC Angled Abutment - 00850008541803

No Description
I3 IMPLANT LLC
i3CCAA
In Commercial Distribution

  • 00850008541803 ()


  • Dental implant suprastructure, temporary, preformed, reusable

CC Straight Abutment - 00850008541797

No Description
I3 IMPLANT LLC
i3CCSA
In Commercial Distribution

  • 00850008541797 ()


  • Dental implant suprastructure, temporary, preformed, reusable

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
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