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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Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11KP
Not in Commercial Distribution

  • 00745129300166 ()

  • Pressure,15-20 mmHg
1102-KP

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11FL
In Commercial Distribution

  • 00745129300159 ()

  • Pressure,15-20 mmHg
1102-FLT

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11FL
In Commercial Distribution

  • 00745129300142 ()

  • Pressure,15-20 mmHg
1102-FLR

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11BP
Not in Commercial Distribution

  • 00745129300135 ()

  • Pressure,15-20 mmHg
1102-BPT

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11BP
Not in Commercial Distribution

  • 00745129300128 ()

  • Pressure,15-20 mmHg
1102-BPR

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11BK
Not in Commercial Distribution

  • 00745129300111 ()

  • Pressure,15-20 mmHg
1102-BKT

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11BK
Not in Commercial Distribution

  • 00745129300104 ()

  • Pressure,15-20 mmHg
1102-BKR

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11TC
Not in Commercial Distribution

  • 00745129300098 ()

  • Pressure,15-20 mmHg
1101-TC

  • General-purpose medical fibre padding
  • General-purpose medical foam padding, single-use
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11KP
Not in Commercial Distribution

  • 00745129300081 ()

  • Pressure,15-20 mmHg
1101-KP

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11FL
In Commercial Distribution

  • 00745129300074 ()

  • Pressure,15-20 mmHg
1101-FLT

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11FL
In Commercial Distribution

  • 00745129300067 ()

  • Pressure,15-20 mmHg
1101-FLR

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11BP
Not in Commercial Distribution

  • 00745129300050 ()

  • Pressure,15-20 mmHg
1101-BPT

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11BP
Not in Commercial Distribution

  • 00745129300043 ()

  • Pressure,15-20 mmHg
1101-BPR

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11BK
Not in Commercial Distribution

  • 00745129300036 ()

  • Pressure,15-20 mmHg
1101-BKT

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11BK
Not in Commercial Distribution

  • 00745129300029 ()

  • Pressure,15-20 mmHg
1101-BKR

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11SE
Not in Commercial Distribution

  • 00745129300012 ()

  • Pressure,15-20 mmHg
1100-SEB

  • General-purpose medical fibre padding
  • General-purpose medical foam padding, single-use
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
11SE
Not in Commercial Distribution

  • 00745129300005 ()

  • Pressure,15-20 mmHg
1100-SE1

  • General-purpose medical fibre padding
  • General-purpose medical foam padding, single-use
No Description
PaloDEx Group Oy
11.x
In Commercial Distribution

  • 06430035872350 ()
213183

  • Stationary panoramic/tomographic dental x-ray system, digital
QTEST™ 11
DFI CO.,LTD
0A94
In Commercial Distribution

  • 08806141300755 ()
  • 08806141300793 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
No Description
BIOTRONIK SE & Co. KG
398789
In Commercial Distribution

  • 04035479135850 ()
398789

  • Cardiac pulse generator analyser cable, single-use
No Description
Icad, Inc.
11
In Commercial Distribution

  • 00850008977343 ()


  • Radiology DICOM image processing application software
AIR11 FILTER, HYPO, 50 PACK
RESMED PTY LTD
39307
In Commercial Distribution

  • 00619498393077 ()
39307

  • Heat/moisture exchanger insertable filter
AIR11 FILTER, HYPO, 12 PACK
RESMED PTY LTD
39306
In Commercial Distribution

  • 00619498393060 ()
39306

  • Heat/moisture exchanger insertable filter
AIR11 FILTER, HYPO, 2 PACK
RESMED PTY LTD
39305
In Commercial Distribution

  • 00619498393053 ()
39305

  • Heat/moisture exchanger insertable filter
AIR11 FILTER, HYPO, 1 PACK
RESMED PTY LTD
39304
In Commercial Distribution

  • 00619498393046 ()
39304

  • Heat/moisture exchanger insertable filter
AIR11 FILTER, STD 50 PACK
RESMED PTY LTD
39303
In Commercial Distribution

  • 00619498393039 ()
39303

  • Home CPAP unit
AIR 11 FILTER, STD 12 PK
RESMED PTY LTD
39302
In Commercial Distribution

  • 00619498393022 ()
39302

  • Home CPAP unit
AIR 11 FILTER, STD 2 PK
RESMED PTY LTD
39301
In Commercial Distribution

  • 00619498393015 ()
39301

  • Home CPAP unit
AIR 11 FILTER STD 1 PK
RESMED PTY LTD
39300
In Commercial Distribution

  • 00619498393008 ()
39300

  • Home CPAP unit
AIR 11 AIR OUTLET
RESMED PTY LTD
39220
In Commercial Distribution

  • 00619498392209 ()
39220

  • Home CPAP unit
AIR 11 PSU 65W USA
RESMED PTY LTD
39205
In Commercial Distribution

  • 00619498392056 ()
39205

  • Home CPAP unit
CLIMATELINEAIR 11 AMER
RESMED PTY LTD
39102
In Commercial Distribution

  • 00619498003273 ()
  • 00619498391028 ()
39102

  • Ventilator breathing circuit, reusable
AIRCURVE 11 VAUTO USA TRI
RESMED PTY LTD
39019
In Commercial Distribution

  • 00619498390199 ()
39019

  • Home BPAP unit
AIRCURVE 11 VAUTO USA CO
RESMED PTY LTD
39018
In Commercial Distribution

  • 00619498390182 ()
39018

  • Home BPAP unit
AIRCURVE 11 ASV USA TRI
RESMED PTY LTD
39013
In Commercial Distribution

  • 00619498390137 ()
39013

  • Home BPAP unit
AIRCURVE 11 ASV USA CO
RESMED PTY LTD
39012
In Commercial Distribution

  • 00619498390120 ()
39012

  • Home BPAP unit
AirSense 11 Elite USA TRI
RESMED PTY LTD
39005
In Commercial Distribution

  • 00619498390052 ()
39005

  • Home CPAP unit
AirSense 11 Elite USA CO
RESMED PTY LTD
39004
In Commercial Distribution

  • 00619498390045 ()
39004

  • Home CPAP unit
AirSense 11 CPAP USA TRI
RESMED PTY LTD
39003
In Commercial Distribution

  • 00619498390038 ()
39003

  • Home CPAP unit
AirSense 11 CPAP USA CO
RESMED PTY LTD
39002
In Commercial Distribution

  • 00619498390021 ()
39002

  • Home CPAP unit
AIRSENSE 11 AUTOSET USA TRI
RESMED PTY LTD
39001
In Commercial Distribution

  • 00619498390014 ()
39001

  • Home CPAP unit
AIRSENSE 11 AUTOSET USA CO
RESMED PTY LTD
39000
In Commercial Distribution

  • 00619498394203 ()
  • 00619498390007 ()
39000

  • Home CPAP unit
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
98330
In Commercial Distribution

  • 09008737983307 ()


  • Audiometric/hearing device software
The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066744 ()

  • 37x19/12mm
CAT371912

  • Metallic spinal interbody fusion cage
The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066720 ()

  • 37x17/10mm
CAT371710

  • Metallic spinal interbody fusion cage
The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066706 ()

  • 37x15/8mm
CAT371508

  • Metallic spinal interbody fusion cage
The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066690 ()

  • 34x18/12mm
CAT341812

  • Metallic spinal interbody fusion cage
The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066676 ()

  • 34x16/10mm
CAT341610

  • Metallic spinal interbody fusion cage
The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066652 ()

  • 34x14/8mm
CAT341408

  • Metallic spinal interbody fusion cage
The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066645 ()

  • 31x17/12mm
CAT311712

  • Metallic spinal interbody fusion cage
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