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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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Biodenta - 07640169735592

Scan Body with Screw Compatible with Straumann Bone Level RC
Biodenta Swiss AG
CAD-SBSBLRC
In Commercial Distribution

  • 07640169735592 ()
CAD-SBSBLRC

  • Dental implant abutment analog, intraoral-scanning, single-use

Biodenta - 07640169735585

Scan Body with Screw Compatible with Straumann Bone Level NC
Biodenta Swiss AG
CAD-SBSBLNC
In Commercial Distribution

  • 07640169735585 ()
CAD-SBSBLNC

  • Dental implant abutment analog, intraoral-scanning, single-use

AF811 - 00606959007673

AF811 Mask with Standard Elbow, with Headgear, Single Use, Medium
Respironics, Inc.
AF811 Mask w/SE, with Headgear, Medium, Single Use
In Commercial Distribution

  • 00606959007673 ()
1063049

  • CPAP/BPAP face mask, single-use

DreamWisp - 00606959057258

DreamWisp Nasal, Medium with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, Medium, Med Connector w/Headgear, APr, AP
In Commercial Distribution

  • 00606959057258 ()
1137944AP

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959054486

DreamWisp Mask, Large with Small/Medium Connector, with Headgear, Korea
Respironics, Inc.
DreamWisp Mask, L, Sm/Med Connector, W/Headgear, KR
Not in Commercial Distribution

  • 00606959054486 ()
1139335

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959051188

DreamWisp Nasal Mask, Large with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, L, S-M-L Connector w/Hdgr, JN
In Commercial Distribution

  • 00606959051188 ()
1137950

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959051171

DreamWisp Nasal Mask, Medium with Small-Medium-Large Connector, With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, M, S-M-L Connector w/HDGR, JN
Not in Commercial Distribution

  • 00606959051171 ()
1137949

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959051065

DreamWisp Nasal Mask, Small with Medium Connector, With Headgear, Global
Respironics, Inc.
DreamWisp Mask, Small, Med Connector w/Headgear, Global
In Commercial Distribution

  • 00606959051065 ()
1137933

  • CPAP/BPAP nasal mask, reusable

DreamStation - 00606959040892

DreamStation BiPAP AVAPS 30 with Humidifier, with Heated Tubing, USA
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Humid w/H Tube,US
In Commercial Distribution

  • 00606959040892 ()
DSX1130T11

  • Portable electric ventilator

AF811 - 00606959007680

AF811 Mask with Standard Elbow, with Headgear, Single Use, Large
Respironics, Inc.
AF811 Mask, w/SE, with Headgear, Large, Single Use
In Commercial Distribution

  • 00606959007680 ()
1063048

  • CPAP/BPAP face mask, single-use
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