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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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EXPRESS LINE DIAMOND - D690161992

EXPRESS LINE DIAMOND TRIMMING WHEEL 12" WITHOUT HOLE - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690161992 ()
16199

  • Diamond dental bur, single-use

EXPRESS LINE DIAMOND - D690161982

EXPRESS LINE DIAMOND TRIMMING WHEEL 10" WITHOUT HOLE - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690161982 ()
16198

  • Diamond dental bur, single-use

EXPRESS LINE DIAMOND - D690161972

EXPRESS LINE DIAMOND TRIMMING WHEEL 12" WITH HOLE - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690161972 ()
16197

  • Diamond dental bur, single-use

EXPRESS LINE DIAMOND - D690161962

EXPRESS LINE DIAMOND TRIMMING WHEEL 10" WITH HOLE - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690161962 ()
16196

  • Diamond dental bur, single-use

EXPRESS LINE DIAMOND - D690SW635190XF2

Express Line Diamond Disc SuperFlex Double Sided HP 635 190XF 1 PACK
Ss White Burs, Inc.
U-SW635-190XF
In Commercial Distribution

  • D690SW635190XF2 ()
SW635190XF

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW394S190F2

Express Line Diamond Disc Sintered Double Sided HP 394S-190F - 1 PACK
Ss White Burs, Inc.
U-SW394S-190F
In Commercial Distribution

  • D690SW394S190F2 ()
SW394S190F

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW393S190M2

Express Line Diamond Disc Sintered Double Sided HP 393S-190M - 1 PACK
Ss White Burs, Inc.
U-SW393S-190M
In Commercial Distribution

  • D690SW393S190M2 ()
SW393S190M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW358220XF2

Express Line Diamond Disc Double Sided HP 358 220XF 1 PACK
Ss White Burs, Inc.
U-SW358-220XF
In Commercial Distribution

  • D690SW358220XF2 ()
SW358220XF

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW355220XF2

Express Line Diamond Disc SuperFlex Double Sided HP 355-220XF - 1 PACK
Ss White Burs, Inc.
U-SW355-220XF
In Commercial Distribution

  • D690SW355220XF2 ()
SW355220XF

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW355220F2

Express Line Diamond Disc SuperFlex Double Sided HP 355 220F 1 PACK
Ss White Burs, Inc.
U-SW355-220F
In Commercial Distribution

  • D690SW355220F2 ()
SW355220F

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW350220M2

Express Line Diamond Disc Double Sided HP 350 220M 1 PACK
Ss White Burs, Inc.
U-SW350-220M
In Commercial Distribution

  • D690SW350220M2 ()
SW350220M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW346220M2

Express Line Diamond Disc Single/Bottom Sided HP 346-220M - 1 PACK
Ss White Burs, Inc.
U-SW346-220M
In Commercial Distribution

  • D690SW346220M2 ()
SW346220M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW346190M2

Express Line Diamond Disc Single/Bottom Sided HP 346-190M - 1 PACK
Ss White Burs, Inc.
U-SW346-190M
In Commercial Distribution

  • D690SW346190M2 ()
SW346190M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW345240M2

Express Line Diamond Disc Double Sided HP 345-240M - 1 PACK
Ss White Burs, Inc.
U-SW345-240M
In Commercial Distribution

  • D690SW345240M2 ()
SW345240M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW345220M2

Express Line Diamond Disc Double Sided HP 345-220M - 1 PACK
Ss White Burs, Inc.
U-SW345-220M
In Commercial Distribution

  • D690SW345220M2 ()
SW345220M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW345190M2

Express Line Diamond Disc Double Sided HP 345-190M - 1 PACK
Ss White Burs, Inc.
U-SW345-190M
In Commercial Distribution

  • D690SW345190M2 ()
SW345190M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690SW345160M2

Express Line Diamond Disc Double Sided HP 345-160M - 1 PACK
Ss White Burs, Inc.
U-SW345-160M
In Commercial Distribution

  • D690SW345160M2 ()
SW345160M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690927S220M2

EXPRESS LINE HP DIAMOND DISC SUPERFLEX VERY FINE 927S-220 DOUBLE SIDED - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690927S220M2 ()
927S220M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690927F200M2

EXPRESS LINE HP DIAMOND DISC FLEX FINE 927F-200 DOUBLE SIDED - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690927F200M2 ()
927F200M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690917S220M2

EXPRESS LINE HP DIAMOND DISC SUPERFLEX VERY FINE 917S-220 SINGLE BOTTOM SIDED - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690917S220M2 ()
917S220M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690917F220M2

EXPRESS LINE HP DIAMOND DISC FLEX FINE 917F-220 SINGLE BOTTOM SIDED - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690917F220M2 ()
917F220M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690917F200M2

EXPRESS LINE HP DIAMOND DISC FLEX FINE 917F-200 SINGLE BOTTOM SIDED - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690917F200M2 ()
917F200M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690916F220M2

EXPRESS LINE HP DIAMOND DISC FLEX FINE 916F-220 SINGLE TOP SIDED - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690916F220M2 ()
916F220M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690916F200M2

EXPRESS LINE HP DIAMOND DISC FLEX FINE 916F-200 SINGLE TOP SIDED - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690916F200M2 ()
916F200M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690927F220M2

EXPRESS LINE HP DIAMOND DISC FLEX FINE 927F-220 DOUBLE SIDED - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690927F220M2 ()
927F220M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690910S220M2

EXPRESS LINE HP DIAMOND DISC SUPERFLEX VERY FINE 910S-220 DOUBLE SIDED - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690910S220M2 ()
910S220M

  • Dental laboratory bur

EXPRESS LINE DIAMOND - D690910S200M2

EXPRESS LINE HP DIAMOND DISC SUPERFLEX VERY FINE 910S-200 DOUBLE SIDED - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690910S200M2 ()
910S200M

  • Dental laboratory bur

GOODWIN LUNG LINE - B0664110100000

A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
NOVOSCI CORP.
411010-000
In Commercial Distribution

  • B0664110100000 ()
  • B0664110100003 ()
411010-000

  • Cardioplegia solution administration adaptor

GOODWIN HEART LINE - B0664110090000

A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during cardiopulmonary bypass procedure by connecting and administration line. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
NOVOSCI CORP.
411009-000
In Commercial Distribution

  • B0664110090003 ()
  • B0664110090000 ()
411009-000

  • Cardioplegia solution administration adaptor

DMSO Extension Line - 07640125650327

Sepax Kit Accessories
Biosafe S.A.
FA-100.1
In Commercial Distribution

  • 07640125650334 ()
  • 07640125650327 ()
10022

  • Blood centrifugation system containment kit

Sterile Sampling Line - 07640125650037

No Description
Biosafe S.A.
AK-101
In Commercial Distribution

  • 07640125650044 ()
  • 07640125650037 ()
10028

  • Blood centrifugation system containment kit

Sterile Sampling Line - 07640125650013

No Description
Biosafe S.A.
AK-100
In Commercial Distribution

  • 07640125650020 ()
  • 07640125650013 ()
10010

  • Blood centrifugation system containment kit

Extension Line, 15cm - 10627825007327

No Description
Laborie Medical Technologies Canada ULC
9021P6351
In Commercial Distribution

  • 20627825007324 ()
  • 10627825007327 ()
  • 30627825007321 ()


  • Arthroscopic shaver system, electrically-powered

Extension Line, 1500mm - 10627825007310

No Description
Laborie Medical Technologies Canada ULC
9021P6332
In Commercial Distribution

  • 20627825007317 ()
  • 10627825007310 ()
  • 30627825007314 ()


  • Arthroscopic shaver system, electrically-powered

MI Product Line - 00816835020829

MI-1000 Minor Surgical Light, Floor Stand with Battery Back-up
Medical Illumination International Inc.
061523B-V
In Commercial Distribution

  • 00816835020829 ()
  • 01816835020828 ()


  • Mobile examination/treatment room light

MI Product Line - 00816835020812

MI-550 Examination Light, Dual Ceiling
Medical Illumination International Inc.
061325-V
In Commercial Distribution

  • 00816835020812 ()
  • 01816835020811 ()


  • Operating room light

MI Product Line - 00816835020805

MI-550 Examination Light, Single Ceiling
Medical Illumination International Inc.
061324-V
In Commercial Distribution

  • 00816835020805 ()
  • 01816835020804 ()


  • Operating room light

MI Product Line - 00816835020799

MI-550 Examination Light, Wall Mount
Medical Illumination International Inc.
061322-V
In Commercial Distribution

  • 00816835020799 ()
  • 01816835020798 ()


  • Operating room light

MI Product Line - 00816835020782

MI-550 Examination Light, Floor Stand
Medical Illumination International Inc.
061323-V
In Commercial Distribution

  • 00816835020782 ()
  • 01816835020781 ()


  • Mobile examination/treatment room light

MI Product Line - 00816835020775

MI-750 Minor Surgical Light, Dual Ceiling
Medical Illumination International Inc.
061425-V
In Commercial Distribution

  • 00816835020775 ()
  • 01816835020774 ()


  • Operating room light

MI Product Line - 00816835020768

MI-750 Minor Surgical Light, Single Ceiling
Medical Illumination International Inc.
061424-V
In Commercial Distribution

  • 00816835020768 ()
  • 01816835020767 ()


  • Operating room light

MI Product Line - 00816835020751

MI-750 Minor Surgical Light, Wall Mount
Medical Illumination International Inc.
061422-V
In Commercial Distribution

  • 00816835020751 ()
  • 01816835020750 ()


  • Operating room light

MI Product Line - 00816835020744

MI-750 Minor Surgical Light, Floor Stand
Medical Illumination International Inc.
061423-V
In Commercial Distribution

  • 00816835020744 ()
  • 01816835020743 ()


  • Mobile examination/treatment room light

MI Product Line - 00816835020737

MI-1000 Minor Surgical Light, Dual Ceiling
Medical Illumination International Inc.
061525-V
In Commercial Distribution

  • 00816835020737 ()
  • 01816835020736 ()


  • Operating room light

MI Product Line - 00816835020720

MI-1000 Minor Surgical Light, Single Ceiling
Medical Illumination International Inc.
061524-V
In Commercial Distribution

  • 00816835020720 ()
  • 01816835020729 ()


  • Operating room light

MI Product Line - 00816835020713

MI-1000 Minor Surgical Light, Wall Mount
Medical Illumination International Inc.
061522-V
In Commercial Distribution

  • 00816835020713 ()
  • 01816835020712 ()


  • Operating room light

MI Product Line - 00816835020706

MI-1000 Minor Surgical Light, Floor Stand
Medical Illumination International Inc.
061523-V
In Commercial Distribution

  • 00816835020706 ()
  • 01816835020705 ()


  • Mobile examination/treatment room light

MI Product Line - 00816835020690

MI-750 Minor Surgical Light, Floor Stand with Battery Back-up
Medical Illumination International Inc.
061413B-V
In Commercial Distribution

  • 00816835020690 ()
  • 01816835020699 ()


  • Mobile examination/treatment room light

MI Product Line - 00816835020683

MI-1000 Minor Surgical Light, Floor Stand with Battery Back-up
Medical Illumination International Inc.
061513B-V
In Commercial Distribution

  • 00816835020683 ()
  • 01816835020682 ()


  • Mobile examination/treatment room light

MI Product Line - 00816835020676

MI-500 Examination Light, Dual Ceiling
Medical Illumination International Inc.
061315-V
In Commercial Distribution

  • 00816835020676 ()
  • 01816835020675 ()


  • Operating room light
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