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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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Sunrise - 05430001896060

Sunrise sensor
Sunrise
1
In Commercial Distribution

  • 05430001896060 ()


  • Home-use sleep apnoea recording system

Sunrise - 05430001896015

Sunrise software
Sunrise
1
In Commercial Distribution

  • 05430001896015 ()


  • Sleep disorder interpretive software, professional-only

NightOwl - 05430001742039

No Description
Ectosense
Mini
In Commercial Distribution

  • 05430001742039 ()
  • 05430001742060 ()


  • Home-use sleep apnoea recording system

NightOwl - 05430001742022

NightOwl sensor kit.
Ectosense
01.00
In Commercial Distribution

  • 05430001742022 ()


  • Home-use sleep apnoea recording system

W-Bone - 05430001477115

W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA200
In Commercial Distribution

  • 05430001477115 ()

  • Weight: 2.0 Gram


  • Dental bone matrix implant, animal-derived

W-Bone - 05430001477108

W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA100
In Commercial Distribution

  • 05430001477108 ()

  • Weight: 1.0 Gram


  • Dental bone matrix implant, animal-derived

W-Bone - 05430001477092

W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA050
In Commercial Distribution

  • 05430001477092 ()

  • Weight: 0.50 Gram


  • Dental bone matrix implant, animal-derived

W-Bone - 05430001477085

W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA025
In Commercial Distribution

  • 05430001477085 ()

  • Weight: 0.25 Gram


  • Dental bone matrix implant, animal-derived

Persyst ESI powered by Epilog - 05430000733045

Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report. Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software

PreOp - 05430000733021

PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software

Medline Industries, Inc. - 10889942206261

CENTRAL LINE DRESSING TRAY
MEDLINE INDUSTRIES, INC.
DYNDC2287A
In Commercial Distribution

  • 10889942206261 ()
DYNDC2287A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206230

C-SECTION PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0129799Q
In Commercial Distribution

  • 10889942206230 ()
  • 40889942206231 ()
DYNJ0129799Q

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206209

OPEN HEART PACK
MEDLINE INDUSTRIES, INC.
DYNJ45630B
In Commercial Distribution

  • 10889942206209 ()
DYNJ45630B

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942206193

C-SECTION PACK
MEDLINE INDUSTRIES, INC.
DYNJ45636B
In Commercial Distribution

  • 10889942206193 ()
DYNJ45636B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206186

VAGINAL DELIVERY PACK
MEDLINE INDUSTRIES, INC.
DYNJ45635C
In Commercial Distribution

  • 10889942206186 ()
DYNJ45635C

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206162

TOTAL HIP
MEDLINE INDUSTRIES, INC.
DYNJ45657A
In Commercial Distribution

  • 10889942206162 ()
  • 40889942206163 ()
DYNJ45657A

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942206155

MINOR
MEDLINE INDUSTRIES, INC.
DYNJ45666A
In Commercial Distribution

  • 40889942206156 ()
  • 10889942206155 ()
DYNJ45666A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206148

LITHOTOMY PACK
MEDLINE INDUSTRIES, INC.
DYNJ45665A
In Commercial Distribution

  • 10889942206148 ()
  • 40889942206149 ()
DYNJ45665A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206131

LAP CHOLE
MEDLINE INDUSTRIES, INC.
DYNJ45664A
In Commercial Distribution

  • 40889942206132 ()
  • 10889942206131 ()
DYNJ45664A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206124

HAND PACK
MEDLINE INDUSTRIES, INC.
DYNJ45655A
In Commercial Distribution

  • 10889942206124 ()
  • 40889942206125 ()
DYNJ45655A

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942206117

CYSTO PACK
MEDLINE INDUSTRIES, INC.
DYNJ45663A
In Commercial Distribution

  • 10889942206117 ()
  • 40889942206118 ()
DYNJ45663A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206100

CATARACT EYE
MEDLINE INDUSTRIES, INC.
DYNJ45662A
In Commercial Distribution

  • 40889942206101 ()
  • 10889942206100 ()
DYNJ45662A

  • General surgical procedure kit, medicated

Medline Industries, Inc. - 10889942206094

C SECTION
MEDLINE INDUSTRIES, INC.
DYNJ45661A
In Commercial Distribution

  • 40889942206095 ()
  • 10889942206094 ()
DYNJ45661A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206087

ARTHROSCOPY PACK
MEDLINE INDUSTRIES, INC.
DYNJ45660A
In Commercial Distribution

  • 10889942206087 ()
DYNJ45660A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206056

PLASTIC EYE
MEDLINE INDUSTRIES, INC.
DYNJ45667A
In Commercial Distribution

  • 40889942206057 ()
  • 10889942206056 ()
DYNJ45667A

  • General surgical procedure kit, medicated

Medline Industries, Inc. - 10889942206049

PELVISCOPY
MEDLINE INDUSTRIES, INC.
DYNJ45659A
In Commercial Distribution

  • 40889942206040 ()
  • 10889942206049 ()
DYNJ45659A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206032

GENERAL LAPAROSCOPY
MEDLINE INDUSTRIES, INC.
DYNJ902093B
In Commercial Distribution

  • 10889942206032 ()
DYNJ902093B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206018

LAPAROSCOPY PACK- GENERAL-LF
MEDLINE INDUSTRIES, INC.
DYNJ28786I
In Commercial Distribution

  • 10889942206018 ()
DYNJ28786I

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942206001

INVASIVE LINE KIT
MEDLINE INDUSTRIES, INC.
DYNDC2300
In Commercial Distribution

  • 10889942206001 ()
DYNDC2300

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942205981

PACEMAKER IMPLANT PACK
MEDLINE INDUSTRIES, INC.
DYNJ48001B
In Commercial Distribution

  • 10889942205981 ()
DYNJ48001B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942205974

ANGIOGRAPHY DRAPE PACK
MEDLINE INDUSTRIES, INC.
DYNJ45654A
In Commercial Distribution

  • 10889942205974 ()
DYNJ45654A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942205967

MAJOR VAGINAL PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0686271D
In Commercial Distribution

  • 10889942205967 ()
DYNJ0686271D

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942205943

DRESSING CHANGE TRAY
MEDLINE INDUSTRIES, INC.
DYNDC2301
In Commercial Distribution

  • 10889942205943 ()
DYNDC2301

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942205936

CFH TURNOVER KIT
MEDLINE INDUSTRIES, INC.
DYKC1161
In Commercial Distribution

  • 10889942205936 ()
DYKC1161

  • General surgical procedure kit, non-medicated, reusable

PreOp - 05430000733007

PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
1.0.0
Not in Commercial Distribution

  • 05430000733007 ()


  • Bioelectrical signal analysis software

AT-Adapt - 05430000620017

AT-Adapt Vented Vial Access Device
YUKON MEDICAL, LLC
ADA010
In Commercial Distribution

  • 05430000620024 ()
  • 05430000620017 ()

  • Lumen/Inner Diameter: 20 Millimeter
ADA010

  • Vial/bottle adaptor, hermetic

Bollard Skeletal Anchor - 05430000515122

No Description
Tita-Link BVBA
BH-UR-19-Y
In Commercial Distribution

  • 05430000515122 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515115

No Description
Tita-Link BVBA
BH-UL-19-Y
In Commercial Distribution

  • 05430000515115 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515108

No Description
Tita-Link BVBA
BH-UR-18-PED
In Commercial Distribution

  • 05430000515108 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515092

No Description
Tita-Link BVBA
BH-UL-18-PED
In Commercial Distribution

  • 05430000515092 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515085

No Description
Tita-Link BVBA
BH-LR-16
In Commercial Distribution

  • 05430000515085 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515078

No Description
Tita-Link BVBA
BH-LL-16
In Commercial Distribution

  • 05430000515078 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515061

No Description
Tita-Link BVBA
BH-UR-21
In Commercial Distribution

  • 05430000515061 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515054

No Description
Tita-Link BVBA
BH-UL-21
In Commercial Distribution

  • 05430000515054 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515047

No Description
Tita-Link BVBA
B-LR-16
In Commercial Distribution

  • 05430000515047 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515030

No Description
Tita-Link BVBA
B-LL-16
In Commercial Distribution

  • 05430000515030 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515023

No Description
Tita-Link BVBA
B-UR-21
In Commercial Distribution

  • 05430000515023 ()


  • Subperiosteal dental implant material

Bollard Skeletal Anchor - 05430000515016

No Description
Tita-Link BVBA
B-UL-21
In Commercial Distribution

  • 05430000515016 ()


  • Subperiosteal dental implant material

Spirotome - 05430000459020

Single Use Spirotome 8G 60mm
Medinvents NV
SS0806
In Commercial Distribution

  • 05430000459020 ()


  • Soft-tissue biopsy procedure kit, non-medicated

Bedal - 05430000258968

Non Sterilized
Bedal
bedal flex XS
In Commercial Distribution

  • 05430000258968 ()

  • Length: 93.9 Millimeter
  • Width: 38.8 Millimeter
  • Height: 6.3 Millimeter
UN-FLEX-NS-XS

  • Synthetic polymer semi-permeable film dressing, adhesive
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