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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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 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-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-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
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
Ambu SPUR II Infant with open reservoir, with Duraclear face mask size neonate, with PEEP valve. 12 pcs/box
Ambu A/S
544211001
In Commercial Distribution

  • 05707480034031 ()
  • 05707480018055 ()

  • Infant
544211001

  • Pulmonary resuscitator, manual, single-use
SPUR II Infant with closed reservoir, with Duraclear face mask sizes infant and neonate, with Manometer 12 pcs/box
Ambu A/S
540216030
In Commercial Distribution

  • 05707480033966 ()
  • 05707480017997 ()

  • Infant
540216030

  • Pulmonary resuscitator, manual, single-use
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
ELVAREX FORTE 3/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES/FOR MAN WITH FLY/NAVY
BSN-Jobst GmbH
77441-00037-00
In Commercial Distribution

  • 04019702457339 ()

  • Pressure 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX FORTE 3/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES/FOR MAN WITH FLY/COCOA
BSN-Jobst GmbH
77441-00053-00
In Commercial Distribution

  • 04019702407297 ()

  • Pressure 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/BERMUDA PANTY/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FOR MAN WITH FLY/CRANBERRY
BSN-Jobst GmbH
79596-00095-00
In Commercial Distribution

  • 04019702623185 ()

  • Pressure 23-32 mmHg
79596-00095-00

  • Compression/pressure sock/stocking, reusable
ELVAREX FORTE 2/ARM SLEEVE WITH SHOULDER CAP AND GLOVE, ONE PIECE/BRA STRAP WITHVELCRO, WITH FINGER, WITH THUMB
BSN-Jobst GmbH
79585-00000-00
In Commercial Distribution

  • 04019702516029 ()

  • Pressure 23-32 mmHg
79585-00000-00

  • Compression/pressure sock/stocking, reusable
ELVAREX 1/BERMUDA PANTY/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FOR MAN WITH FLY/DENIM
BSN-Jobst GmbH
79595-00194-00
In Commercial Distribution

  • 04019702802344 ()

  • Pressure 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/ARM SLEEVE TO AXILLA WITH GLOVE, ONE PIECE/WITH FINGER, WITH THUMB/DOTTED SILICONE BAND INSIDE/BLACK
BSN-Jobst GmbH
77327-00012-00
In Commercial Distribution

  • 04019702317848 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/ARM SLEEVE WITH SHOULDER CAP AND GLOVE, ONE PIECE/BRA STRAP WITHVELCRO, WITH FINGER, WITH THUMB/ZIPPER
BSN-Jobst GmbH
77362-00072-00
In Commercial Distribution

  • 04019702340815 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve with shoulder cap and glove, one piece/Full Compression, Shoulder Strap, with Finger, with Thumb
BSN-Jobst GmbH
77362-00023-00
In Commercial Distribution

  • 04019702340525 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve with shoulder cap and glove, one piece/Bra strap withVelcro, with Finger, with Thumb/Black
BSN-Jobst GmbH
77362-00025-00
In Commercial Distribution

  • 04019702340501 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve with shoulder cap and glove, one piece/Bra strap with Velcro,without Finger,with Thumb
BSN-Jobst GmbH
77362-00000-00
In Commercial Distribution

  • 04019702338416 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/ARM SLEEVE WITH SHOULDER CAP AND GLOVE, ONE PIECE/BRA STRAP WITH VELCRO,WITHOUT FINGER,WITH THUMB
BSN-Jobst GmbH
77329-00000-00
In Commercial Distribution

  • 04019702299342 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Arm sleeve with shoulder cap and glove, one piece/Bra strap withVelcro, with Finger, with Thumb/Black
BSN-Jobst GmbH
77329-00022-00
In Commercial Distribution

  • 04019702298345 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 3/BERMUDA PANTY/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FOR MAN WITH FLY/BLACK
BSN-Jobst GmbH
79597-00011-00
In Commercial Distribution

  • 04019702278552 ()

  • Pressure 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
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
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
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
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
Semkin Bipolar Forcep Straight Overall Length 5 1/2" (139.7mm) With A With A 0.7mm Tip With Travel Stop
TITAN MANUFACTURING INC
161610121040101
In Commercial Distribution

  • 00817914020341 ()

  • Length: 5.5 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
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
For use with US Endoscopy CO2 Insufflators in conjunction with medical grade CO2 cylinders with DIN 477 standard connectors.
US Endoscopy
390513
Not in Commercial Distribution

  • 00816765013182 ()
390513

  • High-pressure medical gas hose
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
The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Neuropace, Inc.
DL-344-3.5-K
In Commercial Distribution

  • 00855547005359 ()

  • Length: 44 Centimeter
  • 4 electrodes with 3.5 mm spacing


  • Brain-responsive electrical stimulation system
The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Neuropace, Inc.
DL-330-3.5-K
In Commercial Distribution

  • 00855547005342 ()

  • 4 electrodes with 3.5 mm spacing
  • Length: 30 Centimeter


  • Brain-responsive electrical stimulation system
The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Neuropace, Inc.
DL-330-10-K
In Commercial Distribution

  • 00855547005335 ()

  • 4 electrodes with 10 mm spacing
  • Length: 30 Centimeter


  • Brain-responsive electrical stimulation system
The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.
Neuropace, Inc.
CL-315-10-K
In Commercial Distribution

  • 00855547005328 ()

  • Length: 15 Centimeter
  • 4 electrodes with 10 mm spacing


  • Brain-responsive electrical stimulation system
The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.
Neuropace, Inc.
CL-325-10-K
In Commercial Distribution

  • 00855547005311 ()

  • 4 electrodes with 10 mm spacing
  • Length: 25 Centimeter


  • Brain-responsive electrical stimulation system
The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.
Neuropace, Inc.
CL-335-10-K
In Commercial Distribution

  • 00855547005304 ()

  • Length: 35 Centimeter
  • 4 electrodes with 10 mm spacing


  • Brain-responsive electrical stimulation system
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