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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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Ambu SPUR II Infant with closed reservoir, with Duraclear face mask size neonate, with PEEP valve. 12 pcs/box
Ambu A/S
540211001
In Commercial Distribution

  • 05707480033874 ()
  • 05707480017959 ()

  • Infant
540211001

  • Pulmonary resuscitator, manual, single-use
Ambu SPUR II Pediatric with closed reservoir, with Duraclear face mask size infant, with PEEP valves. 12 pcs/box
Ambu A/S
530212001
In Commercial Distribution

  • 05707480033263 ()
  • 05707480017485 ()

  • Pediatric
530212001

  • Pulmonary resuscitator, manual, single-use
For use with US Endoscopy CO2 Insufflators in conjunction with medical grade CO2 cylinders with DIN 477 standard connectors.
US Endoscopy
390513
In Commercial Distribution

390513

  • High-pressure medical gas hose
The G Remote Power Control-Triple with Camera with Battery Boost Module is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995167738 ()
LGH00000064

  • Medical monitor/light mount
The G Remote Power Control-Single with Camera with Battery Boost Module is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995167714 ()
LGH00000054

  • Medical monitor/light mount
The G5 Single Light with Camera-Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167110 ()
LGH08NT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G5 Single Fixed with Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166823 ()
LG07NFT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G Remote Power Control-Dual with Camera with Battery Boost Module is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
In Commercial Distribution

  • 00724995167721 ()
LGH00000058

  • Medical monitor/light mount
Lambotte Bone Holding Forcep With Swivel Head Adjustable Jaw With Click Ratchet With Overall Length 8 1/2" (216mm)
Med Saver, Inc.
D7204
In Commercial Distribution

  • 00194613079529 ()


  • Orthopaedic bone-fragment manipulator, reusable
ELMED ESU 400 WITH SMART-O-MATIC CIRCUIT, MONOPOLAR AND BIPOLAR, WITH RETURN ELECTRODE MONITOR (REM), COMPATIBLE WITH DUAL-CONTACT PATIENT PLATES
ELMED INCORPORATED
5757
In Commercial Distribution

  • 00842180106000 ()
5757

  • Electrosurgical system generator
NEEDLE HOLDER INSERT WITH SHEATH Ø 5MM curved right with carbide metal insert, WL 410mm, with irrigation connection, reusable
Richard Wolf GmbH
8394514
In Commercial Distribution

  • 04055207016596 ()

  • Outer Diameter: 5 Millimeter
8394.514

  • Suturing needle holder, reusable
NEEDLE HOLDER INSERT WITH SHEATH Ø 5MM curved right with carbide metal insert, WL 320mm, with irrigation connection, reusable
Richard Wolf GmbH
8393514
In Commercial Distribution

  • 04055207016152 ()

  • Outer Diameter: 5 Millimeter
8393.514

  • Suturing needle holder, reusable
Table-/ floor column with top plate, column L 500mm with cable pass thru, base plate with cable pass thru
CIM med GmbH
T-CTP-60.w1_500
In Commercial Distribution

  • 04061162008132 ()


  • Medical monitor/light mount
Table-/ floor column with top plate, column L 300mm with cable pass thru, base plate with cable pass thru
CIM med GmbH
T-CTP-60.w1_300
In Commercial Distribution

  • 04061162008125 ()


  • Medical monitor/light mount
Fiber Optic Retractor With Suction, 1 Inch X 6 Inch Blade With Right Angle Tip With Teeth, Autoclavable Non-
Surgical Direct, Inc.
SD12343-FST
In Commercial Distribution

  • B382SD12343FST0 ()
SD12343-FST

  • Fibreoptic retractor handle
TruShot™ with Y-Knot® 1.3 mm All-Suture Anchor with one #2 (5 metric) Hi-Fi® Suture with Needles
Conmed Corporation
Y13TN
In Commercial Distribution

Y13TN

  • Tendon/ligament bone anchor, non-bioabsorbable
TruShot™ with Y-Knot® 1.8 mm All-Suture Anchor with two #2 (5 metric) Hi-Fi® Sutures with Needles
Conmed Corporation
Y18TN
Not in Commercial Distribution

  • 30845854850071 ()
Y18TN

  • Tendon/ligament bone anchor, non-bioabsorbable
TruShot™ with Y-Knot® 1.3 mm All-Suture Anchor with one #2 (5 metric) Hi-Fi® Suture with Needles
Conmed Corporation
Y13TN
Not in Commercial Distribution

  • 30845854850064 ()
Y13TN

  • Tendon/ligament bone anchor, non-bioabsorbable
DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS
Tensproducts, LLC
COMFYCOMBOPLUS
In Commercial Distribution

  • 10816924020249 ()
  • 00816924020372 ()
  • 00816924020242 ()
  • 00816924020778 ()
  • 10816924020775 ()
  • 00816924020730 ()
COMFYCOMBOPLUS, COMFYCOMBOPLUS-JETT, COMFYCOMBOPLUS-TP,COMFYCOMBOPLUS-MFR

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The Duo Double Electric Breast Pump is a single user, double electric breast pump that includes customizable massage and expression modes and is capable of single and double pumping.
Bistos Co., Ltd.
AAA0021
In Commercial Distribution

  • 00887529000465 ()
  • 00887529000472 ()
  • 10887529000479 ()
  • 00887529000489 ()
  • 10887529000486 ()


  • Breast pump, electric
The Duo Double Electric Breast Pump is a single user, double electric breast pump that includes customizable massage and expression modes and is capable of single and double pumping.
Bistos Co., Ltd.
MD-20.2
In Commercial Distribution

  • 00887529000151 ()
  • 00887529000175 ()
  • 10887529000172 ()
  • 00887529000205 ()
  • 10887529000202 ()


  • Breast pump, electric
AQUAbase nX 750HT (60Hz/208-220V)
B.Braun Avitum AG
LA1101376
In Commercial Distribution

  • 04046955725175 ()
LA1101376

  • Reverse-osmosis water purification system
AQUAbase® nX HT 500 Reverse Osmosis System
B.Braun Avitum AG
LA1101351
In Commercial Distribution

  • 04046955725168 ()
LA1101351

  • Reverse-osmosis water purification system
AQUAbase® nX HT 250 Reverse Osmosis System
B.Braun Avitum AG
LA1101326
In Commercial Distribution

  • 04046955725151 ()
LA1101326

  • Reverse-osmosis water purification system
CATHETER, IV, SURESITE AUTO, 16G X 1.77"
MEDLINE INDUSTRIES, INC.
DYNA16177
In Commercial Distribution

  • 30193489140136 ()
  • 20193489140139 ()
  • 10193489140132 ()
DYNA16177

  • Peripheral intravenous cannula
CATHETER, IV, SURESITE AUTO, 18G X 1.16"
MEDLINE INDUSTRIES, INC.
DYNA18116
In Commercial Distribution

  • 20193489140122 ()
  • 10193489140125 ()
  • 30193489140129 ()
DYNA18116

  • Peripheral intravenous cannula
CATHETER, IV, SURESITE AUTO, 18G X 1.88"
MEDLINE INDUSTRIES, INC.
DYNA18188
In Commercial Distribution

  • 30193489140112 ()
  • 20193489140115 ()
  • 10193489140118 ()
DYNA18188

  • Peripheral intravenous cannula
CATHETER, IV, SURESITE AUTO, 20G X 1.00"
MEDLINE INDUSTRIES, INC.
DYNA20100
In Commercial Distribution

  • 20193489140108 ()
  • 30193489140105 ()
  • 10193489140101 ()
DYNA20100

  • Peripheral intravenous cannula
Thermoplastic disk used to make custom temporary crown and bridge restorations
ADVANTAGE DENTAL PRODUCTS INC
100
In Commercial Distribution

  • 10859787002052 ()
  • 00859787002055 ()
  • 00859787002222 ()


  • Dental appliance fabrication material, thermoplastic
NDL SP S/SU 25GA 4-11/16IN WHITACRE CE
BECTON, DICKINSON AND COMPANY
400372
In Commercial Distribution

  • 30382904003723 ()
  • 00382904003722 ()
  • 50382904003727 ()

  • Length: 119.1 Millimeter
  • Needle Gauge: 25 Gauge
400372

  • Spinal needle, single-use
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