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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D'Assumpcao Facelift Marker With Ratchet 6" (152mm) With A Width Of 8mm
Med Saver, Inc.
402P
In Commercial Distribution

  • 00194613094928 ()


  • Skin marking guide, reusable
Silver Osteotome Straight With Overall Length 7" (178mm) With Single Guard Straight
Med Saver, Inc.
E8100
In Commercial Distribution

  • 00194613094607 ()


  • Orthopaedic osteotome
Bishop Bone Holidng Forcep With Overall Length 9" (229mm) With Adjustable Jaw
Med Saver, Inc.
D7202
In Commercial Distribution

  • 00194613079512 ()


  • Orthopaedic bone-fragment manipulator, reusable
Lane Bone Forcept With Ratchet With Overall Length 17" (432mm) Heavy Model
Med Saver, Inc.
D7084
In Commercial Distribution

  • 00194613079352 ()


  • Orthopaedic bone-fragment manipulator, reusable
LimbLogic 2000 with Fob, Unilateral Kit with 4-Hole Pin Lock Adapter Plate
Willowwood Global LLC
LLV-2000-P
In Commercial Distribution

  • 00194711300341 ()
LLV-2000-P

  • External lower-limb prosthesis suspensory component, powered
OUTER TUBE WITH HANDLE Ø 4.7MM SL 410MM with bipolar HF-connection, reusable
Richard Wolf GmbH
8384974
Not in Commercial Distribution

  • 04055207015308 ()

  • Outer Diameter: 4.7 Millimeter
  • Length: 410 Millimeter
8384.974

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
OUTER TUBE WITH HANDLE Ø 4.7MM SL 285MM with bipolar HF-connection, reusable
Richard Wolf GmbH
8383974
Not in Commercial Distribution

  • 04055207015254 ()

  • Outer Diameter: 4.7 Millimeter
  • Length: 285 Millimeter
8383.974

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
AF531 Mask with Standard Elbow, with 4 Point Headgear, Single Use, Small
Respironics, Inc.
AF531 Mask w/SE, with 4 point Headgear, Small, Single Use
Not in Commercial Distribution

  • 00606959007451 ()
1061721

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, Leak 2, with CapStrap, Single Use, Medium
Respironics, Inc.
AF531 Mask EE, Leak 2, w/CapStrap, Medium, SU
In Commercial Distribution

  • 30606959007377 ()
  • 00606959007376 ()
1119019

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, Nebulizing Elbow, with CapStrap, Single Use, Large
Respironics, Inc.
00606959007352
Not in Commercial Distribution

  • 30606959007353 ()
  • 00606959007352 ()
1119017

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, Nebulizing Elbow, with CapStrap, Single Use, Small
Respironics, Inc.
AF531 Mask w/SE, Nebulizing Elbow, w/CapStrap, Small, SU
Not in Commercial Distribution

  • 30606959007339 ()
  • 00606959007338 ()
1119015

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, LEAK 1, with CapStrap, Large, Single Use
Respironics, Inc.
AF531 Mask EE, LEAK 1, with CapStrap, Large, Single Use
In Commercial Distribution

  • 30606959004604 ()
  • 00606959004603 ()
1119011

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, with 4 Point Headgear, Single Use, Large
Respironics, Inc.
AF531 Mask w/SE, with 4 point Headgear, Large, SU
Not in Commercial Distribution

  • 00606959007475 ()
1061723

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

  • 00606959007468 ()
1061722

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, Leak 2, with CapStrap, Single Use, Small
Respironics, Inc.
AF531 Mask EE, Leak 2, with W/CapStrap, Small, SU
In Commercial Distribution

  • 30606959007360 ()
  • 00606959007369 ()
1119018

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, Nebulizing Elbow, with CapStrap, Single Use, Medium
Respironics, Inc.
AF531 Mask w/SE, Nebulizing Elbow, w/CapStrap, Medium, SU
Not in Commercial Distribution

  • 30606959007346 ()
  • 00606959007345 ()
1119016

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, LEAK 1, with CapStrap, Medium, Single Use
Respironics, Inc.
AF531 Mask EE, LEAK 1, with CapStrap, Medium, Single Use
In Commercial Distribution

  • 30606959004598 ()
  • 00606959004597 ()
1119010

  • CPAP/BPAP face mask, single-use
DreamWisp Nasal Mask, Extra Large with Small Medium Connector, with Headgear, Korea
Respironics, Inc.
DreamWisp Mask, XL, Sm/Med Connector, W/Headgear, KR
Not in Commercial Distribution

  • 00606959054493 ()
1139336

  • CPAP/BPAP nasal mask, reusable
Adult Nasal Pressure Monitoring Cannula with 7' (2.1 m) tube with filter.
SALTER LABS
5011-7
In Commercial Distribution

  • 10607411500135 ()
  • 00607411500138 ()

  • Adult
5011-7

  • Respiratory apnoea monitoring system
Adult Nasal Pressure Monitoring Cannula with 1' (.3 m) tube with filter.
SALTER LABS
5011-1
In Commercial Distribution

  • 10607411007979 ()
  • 00607411007972 ()
  • 20607411007419 ()

  • Adult
5011-1

  • Respiratory apnoea monitoring system
Adult Nasal Pressure Monitoring Cannula with 2' (.6 m) tube with filter.
SALTER LABS
5011-2
In Commercial Distribution

  • 10607411007962 ()
  • 00607411007965 ()

  • Adult
5011-2

  • Respiratory apnoea monitoring system
AF541 Under the Nose Mask, with Standard Elbow, with Capstrap, SIZE B
Respironics, Inc.
AF541 Mask, SE, Under Nose, w/Capstrap, SIZE B
In Commercial Distribution

  • 30606959046697 ()
  • 00606959046696 ()
1133718

  • CPAP/BPAP face mask, single-use
AF541 Under the Nose Mask with Standard Elbow, with Capstrap, SIZE A
Respironics, Inc.
AF541 Mask, SE, Under Nose, w/Capstrap, SIZE A
In Commercial Distribution

  • 30606959046680 ()
  • 00606959046689 ()
1133717

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with Capstrap, Size S, Japan
Respironics, Inc.
AF541 Mask EE, Leak 1, with Capstrap, Small, JP
Not in Commercial Distribution

  • 30606959041272 ()
  • 00606959041271 ()
1129500

  • CPAP/BPAP face mask, single-use
DreamStation BiPAP AVAPS 30 with Humidifier, with Heated Tubing, No BlueTooth, International
Respironics, Inc.
DreamStation BiPAP AVAPS 30 w/Hum w/HTube, No BT, INTL
In Commercial Distribution

  • 00606959040984 ()
INX1130T19

  • Portable electric ventilator
DreamStation BiPAP S/T25 with Humidifier, with Heated Tube, no BlueTooth, International
Respironics, Inc.
DreamStation BiPAP S/T25 w/Hum w/H Tube, no BT, INTL
In Commercial Distribution

  • 00606959040717 ()
INX1025T19

  • Portable electric ventilator
REMstar Auto with Heated Humidifier, with BlueTooth, System One 60 Series, Canada
Respironics, Inc.
REMstar Auto w/HTD Humid, BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959037762 ()
CA561TBT

  • Home CPAP unit
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
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
AF541 Mask with Entrainment Elbow, Leak 1, with Four Point Headgear, Small
Respironics, Inc.
AF541 Mask EE, Leak 1, w/ 4 Point Headgear, Small
In Commercial Distribution

  • 30606959024367 ()
  • 00606959024366 ()
1121058

  • CPAP/BPAP face mask, single-use
DreamStation Auto BiPAP with Humidifier, with Heated Tube, American Home Patient (AHP)
Respironics, Inc.
DreamStation Auto BiPAP w/Humid, w/H Tube, AHP
Not in Commercial Distribution

  • 00606959022621 ()
AHX700T11

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

  • 00606959022577 ()
AHX500T11

  • Home CPAP unit
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
Catheter with Outer Stiffener with Stainless Steel Core, 10cm, model number Type5-v4
KITAZATO CORPORATION
131106 Type5-v4
In Commercial Distribution

  • 14580303269265 ()
  • 04580303269268 ()
131106

  • Assisted reproduction transfer catheter/set
Catheter with Outer Stiffener with Stainless Steel Core, 10cm, model number Type5-v3
KITAZATO CORPORATION
131101 Type5-v3
In Commercial Distribution

  • 14580303269258 ()
  • 04580303269251 ()
131101

  • Assisted reproduction transfer catheter/set
Catheter with Outer Stiffener with Stainless Steel Core, 18cm, model number Type5-v2
KITAZATO CORPORATION
131186 Type5-v2
In Commercial Distribution

  • 14580303269241 ()
  • 04580303269244 ()
131186

  • Assisted reproduction transfer catheter/set
Catheter with Outer Stiffener with Stainless Steel Core, 18cm, model number Type5-v1
KITAZATO CORPORATION
131181 Type5-v1
In Commercial Distribution

  • 14580303269234 ()
  • 04580303269237 ()
131181

  • Assisted reproduction transfer catheter/set
Bowl with High Vacuum Blades and Cement Cartridge with Breakaway Femoral Nozzle
STRYKER CORPORATION
0306564000
In Commercial Distribution

  • 34546540899072 ()
  • 04546540899071 ()

  • Weight: 180.0 Gram
0306564000

  • Manual orthopaedic cement mixer, reusable
Plus Handpiece with Suction Tubing and Trauma Tip with Small Soft Cone
STRYKER CORPORATION
0207590000
In Commercial Distribution

  • 34546540860737 ()
  • 04546540860736 ()
0207590000

  • Disposable surgical irrigation/aspiration system
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