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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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MXi Tip-Edge Brackets - 00192029006450

UPPER & LOWER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
TP ORTHODONTICS INC
298-803F
In Commercial Distribution

  • 00192029006450 ()


  • Orthodontic bracket, ceramic

MXi Tip-Edge Brackets - 00192029006443

UPPER 5-5 NON-EXTRACTION KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
TP ORTHODONTICS INC
298-802F
In Commercial Distribution

  • 00192029006443 ()


  • Orthodontic bracket, ceramic

V. Mueller - 10885403095276

V. Mueller KOCH NUCLEUS SPATULA, GENTLY CURVED WITH DUCKBILL TIP, WITH NOTCHES
STERIS CORPORATION
OP0921-402
In Commercial Distribution

  • 10885403095276 ()
OP0921402

  • Ophthalmic surgical probe, reusable

DreamStation - 00606959022607

DreamStation BiPAP Pro with Humidifier, with Heated Tube, American Home Patient (AHP)
Respironics, Inc.
DreamStation BiPAP Pro w/Humid w/H Tube, AHP
Not in Commercial Distribution

  • 00606959022607 ()
AHX600T11

  • Home BPAP unit

DreamStation - 00606959022454

DreamStation CPAP Pro with Humidifier, with Heated Tube, American Home Patient (AHP)
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/H Tube, AHP
Not in Commercial Distribution

  • 00606959022454 ()
AHX400T11

  • Home CPAP unit

DreamWear - 00606959030916

DreamWear Under the Nose Nasal Mask, with Medium Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, M Frame w/Headgr, Global
In Commercial Distribution

  • 00606959030916 ()
1116700

  • CPAP/BPAP nasal mask, reusable

AF531 - 00606959028968

AF531 Mask with Entrainment Elbow, Leak 1, with CapStrap, Single, Medium, China
Respironics, Inc.
AF531 Mask EE, Leak1 with CapStrap, Medium, China
Not in Commercial Distribution

  • 00606959028968 ()
CN1061728

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024540

AF541 Mask with Entrainment Elbow, Leak 2, with Four Point Headgear, Large
Respironics, Inc.
AF541 Mask EE, Leak 2 with 4-Point Headgear, Large
In Commercial Distribution

  • 30606959024541 ()
  • 00606959024540 ()
1121068

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024458

AF541 Mask with Entrainment Elbow, Leak 1, with 4 Point Headgear, Medium
Respironics, Inc.
AF541 Mask EE, Leak 1, with 4 Point Headgear, Medium
In Commercial Distribution

  • 30606959024459 ()
  • 00606959024458 ()
1121489

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024397

AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with 4 Point Headgear, XLarge
In Commercial Distribution

  • 30606959024398 ()
  • 00606959024397 ()
1121061

  • CPAP/BPAP face mask, single-use
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