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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golden handle 2 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-02
In Commercial Distribution

  • 04250676732248 ()
20-425-02

  • Plastic surgery osteotome
golden handle 2.5 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-25
In Commercial Distribution

  • 04250676732347 ()
20-425-25

  • Plastic surgery osteotome
guarded, golden handle 2.2 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-426-00
In Commercial Distribution

  • 04250676732330 ()
20-426-00

  • Plastic surgery osteotome
golden handle 14 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-14
In Commercial Distribution

  • 04250676732309 ()
20-425-14

  • Plastic surgery osteotome
golden handle 10 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-10
In Commercial Distribution

  • 04250676732286 ()
20-425-10

  • Plastic surgery osteotome
golden handle 3 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-03
In Commercial Distribution

  • 04250676732255 ()
20-425-03

  • Plastic surgery osteotome
EXPRESS LINE HP DIAMOND 863-030 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162110 ()
  • D690162112 ()
16211

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 859-030 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162100 ()
  • D690162102 ()
16210

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 854R-040 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162090 ()
  • D690162092 ()
16209

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 854-040 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162080 ()
  • D690162082 ()
16208

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 848-030 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162070 ()
  • D690162072 ()
16207

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 845-020 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162060 ()
  • D690162062 ()
16206

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 806-030 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162050 ()
  • D690162052 ()
16205

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 805-040 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162040 ()
  • D690162042 ()
16204

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 805-030 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162030 ()
  • D690162032 ()
16203

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 805-020 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162020 ()
  • D690162022 ()
16202

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 801-030 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162010 ()
  • D690162012 ()
16201

  • Diamond dental bur, single-use
EXPRESS LINE HP DIAMOND 801-020 - 5 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690162000 ()
  • D690162002 ()
16200

  • Diamond dental bur, single-use
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 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 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 TRIMMING WHEEL 10" WITH HOLE - 1 PACK
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690161962 ()
16196

  • Diamond dental bur, single-use
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 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
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 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 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 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 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 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 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 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
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
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
H2H Rinse Line and packaging information
NEPHROS, INC.
70-5827
Not in Commercial Distribution

  • 10896241002364 ()
  • 00896241002367 ()


  • Haemodialysis water purification system washer-disinfector (thermal)
Sepax Kit Accessories
Biosafe S.A.
FA-100.1
In Commercial Distribution

  • 07640125650334 ()
  • 07640125650327 ()
10022

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
AK-101
In Commercial Distribution

  • 07640125650044 ()
  • 07640125650037 ()
10028

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
AK-100
In Commercial Distribution

  • 07640125650020 ()
  • 07640125650013 ()
10010

  • Blood centrifugation system containment kit
No Description
Laborie Medical Technologies Canada ULC
9021P6351
In Commercial Distribution

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


  • Arthroscopic shaver system, electrically-powered
No Description
Laborie Medical Technologies Canada ULC
9021P6332
In Commercial Distribution

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


  • Arthroscopic shaver system, electrically-powered
MI-750 Minor Surgical Light, Floor Stand with Battery Back-up
Medical Illumination International Inc.
061423B-V
In Commercial Distribution

  • 00816835020836 ()
  • 01816835020835 ()


  • Mobile examination/treatment room light
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-550 Examination Light, Dual Ceiling
Medical Illumination International Inc.
061325-V
In Commercial Distribution

  • 00816835020812 ()
  • 01816835020811 ()


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

  • 00816835020805 ()
  • 01816835020804 ()


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

  • 00816835020799 ()
  • 01816835020798 ()


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

  • 00816835020782 ()
  • 01816835020781 ()


  • Mobile examination/treatment room light
MI-750 Minor Surgical Light, Single Ceiling
Medical Illumination International Inc.
061424-V
In Commercial Distribution

  • 00816835020768 ()
  • 01816835020767 ()


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

  • 00816835020744 ()
  • 01816835020743 ()


  • Mobile examination/treatment room light
MI-1000 Minor Surgical Light, Single Ceiling
Medical Illumination International Inc.
061524-V
In Commercial Distribution

  • 00816835020720 ()
  • 01816835020729 ()


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

  • 00816835020706 ()
  • 01816835020705 ()


  • Mobile examination/treatment room light
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