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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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PreFAB-4 Blank with Screw compatible with Nobel Replace NP Narrow D9.9
Biodenta Swiss AG
CAD-TPNRNPNS
In Commercial Distribution

  • 07640169731747 ()
CAD-TPNRNPNS

  • Dental implant suprastructure, permanent, preformed
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Mini IOS
Biodenta Swiss AG
CAD-SBOTS35
In Commercial Distribution

  • 07640169731402 ()
CAD-SBOTS35

  • Dental implant abutment analog, intraoral-scanning, single-use
UPPER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
TP ORTHODONTICS INC
298-801F
In Commercial Distribution

  • 00192029006436 ()


  • Orthodontic bracket, ceramic
LOWER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
TP ORTHODONTICS INC
298-807F
In Commercial Distribution

  • 00192029006474 ()


  • Orthodontic bracket, ceramic
Bone holding clamp with hole - ring handle with ratchet - 15 cm
Kohler Medizintechnik GmbH
7247
In Commercial Distribution

  • 04251436923494 ()
7247

  • Bone holding forceps
Salter Air Elite® with NebuTech® HDN®, with Nebulizer.
SALTER LABS
8352-8984-7-1
In Commercial Distribution

  • 00607411102110 ()
8352-8984-7-1

  • Benchtop nebulizer, non-heated
DreamWisp Nasal, Extra Large with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, XL, Med Connector w/Headgear, AP
In Commercial Distribution

  • 00606959057272 ()
1137946AP

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Medium with Small Medium Connector, with Headgear, Korea
Respironics, Inc.
DreamWisp Mask, Med, Sm/Med CONNECTOR, W/Headgear, KR
Not in Commercial Distribution

  • 00606959054479 ()
1139334

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Petite with Small Medium Connector, with Headgear, Korea
Respironics, Inc.
DreamWisp Mask, Petite, Sm/Med CONNECTOR, w/Headgear, KR
Not in Commercial Distribution

  • 00606959054455 ()
1139332

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Extra Large with Medium Connector With Headgear, International
Respironics, Inc.
DreamWisp Mask, Xlarge, MedConnector, wHeadgear, INTL
In Commercial Distribution

  • 00606959051140 ()
1137946

  • CPAP/BPAP nasal mask, reusable
Salter Air Elite® with NebuTech® HDN®, with Nebulizer
SALTER LABS
8352-8660-7-1
In Commercial Distribution

  • 00607411001536 ()
8352-8660-7-1

  • Benchtop nebulizer, non-heated
DreamWisp Nasal, Petite with Medium Connector with Headgear, Central Eastern Europe
Respironics, Inc.
DreamWisp Mask, Petite, Med Connector w/Headgear, CEE
In Commercial Distribution

  • 00606959057289 ()
1137942CE

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Small with Small Medium Connector with Headgear, Korea
Respironics, Inc.
DREAMWISP Mask, Small, Sm/Med Connector W/Headgear, KR
Not in Commercial Distribution

  • 00606959054462 ()
1139333

  • CPAP/BPAP nasal mask, reusable
AF531 Mask with Entrainment Elbow, with 4 Point Headgear, Medium, USA
Respironics, Inc.
AF531 Mask EE with 4 point Headgear, Medium, USA
In Commercial Distribution

  • 30606959012234 ()
  • 00606959012233 ()
1094800

  • CPAP/BPAP face mask, single-use
DreamStation Auto CPAP with Humidifier, with Heated Tube, and WiFi, Domestic
Respironics, Inc.
DreamStation Auto CPAP w/Humid w/H Tube w/WiFi, US
In Commercial Distribution

  • 00606959034129 ()
DSX500T11W

  • Home CPAP unit
DreamWear Gel Pillows Mask, Large, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, Large, L Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026971 ()
1125023

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Small, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, S, Large Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026957 ()
1125021

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Small, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, S, Small Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026926 ()
1125018

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Medium, with Medium Frame with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, M, Med Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026902 ()
1125016

  • CPAP/BPAP nasal mask, reusable
AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, X-LARGE
In Commercial Distribution

  • 30606959024596 ()
  • 00606959024595 ()
1121073

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 2, with Four-Point Headgear, Small
Respironics, Inc.
AF541 Mask EE, Leak 2 with 4 Point Headgear, Small
In Commercial Distribution

  • 30606959024527 ()
  • 00606959024526 ()
1121066

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with Capstrap, XLarge, US
In Commercial Distribution

  • 30606959024435 ()
  • 00606959024434 ()
1121065

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Large
Respironics, Inc.
AF541 Mask EE, Leak 1, w/ 4 Point Headgear, Large
In Commercial Distribution

  • 30606959024381 ()
  • 00606959024380 ()
1121060

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Medium
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ 4 Point Headgear,Medium
In Commercial Distribution

  • 30606959024374 ()
  • 00606959024373 ()
1121059

  • CPAP/BPAP face mask, single-use
ComfortGel Blue Nasal Mask with Standard Elbow, with Headgear, Small, International
Respironics, Inc.
ComfortGel Blue Nasal Mask w/SE, w/Headgr, Small, INTL
In Commercial Distribution

  • 00606959020825 ()
1070070

  • CPAP/BPAP nasal mask, reusable
ComfortGel Blue Nasal Mask with Standard Elbow, with Headgear, Large, International
Respironics, Inc.
ComfortGel Blue Nasal Mask w/SE, w/Headgr, Large, INTL
In Commercial Distribution

  • 00606959020818 ()
1070068

  • CPAP/BPAP nasal mask, reusable
AF531 Mask with Entrainment Elbow (Nebulizing Elbow) with CapStrap, USA, Large
Respironics, Inc.
AF531 Mask EE (Nebulizing Elbow) with CapStrap, Large, USA
Not in Commercial Distribution

  • 30606959012395 ()
  • 00606959012394 ()
1094816

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, with 4 Point Headgear, Medium, USA
Respironics, Inc.
AF531 Mask w/SE, with 4 PT Headgear, Medium, USA
Not in Commercial Distribution

  • 30606959012326 ()
  • 00606959012325 ()
1094809

  • CPAP/BPAP face mask, single-use
DreamWear Gel Pillows Mask, Medium, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, M, L Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026964 ()
1125022

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Large, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, L , Sm Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026940 ()
1125020

  • CPAP/BPAP nasal mask, reusable
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