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 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
golden handle 16 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-16
In Commercial Distribution

  • 04250676734136 ()
20-425-16

  • Plastic surgery osteotome
curved, pointed 11.5 cm
Spiggle & Theis Medizintechnik GmbH
20-648-12
In Commercial Distribution

  • 04250676741820 ()
20-648-12

  • Nasal scissors
straight, pointed 11.5 cm
Spiggle & Theis Medizintechnik GmbH
20-647-12
In Commercial Distribution

  • 04250676741813 ()
20-647-12

  • Nasal scissors
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 18 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-18
In Commercial Distribution

  • 04250676732323 ()
20-425-18

  • 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 12 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-12
In Commercial Distribution

  • 04250676732293 ()
20-425-12

  • 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 6 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-06
In Commercial Distribution

  • 04250676732279 ()
20-425-06

  • Plastic surgery osteotome
golden handle 4 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-04
In Commercial Distribution

  • 04250676732262 ()
20-425-04

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

  • 04250676732248 ()
20-425-02

  • Plastic surgery osteotome
TC, curved, pointed, DLC coating wavecut, 11.5 cm
Spiggle & Theis Medizintechnik GmbH
10-535-12WB
In Commercial Distribution

  • 04250676729095 ()
10-535-12WB

  • Ear scissors, reusable
TC, curved, pointed, DLC coating 11.5 cm
Spiggle & Theis Medizintechnik GmbH
10-535-12B
In Commercial Distribution

  • 04250676729088 ()
10-535-12B

  • Ear scissors, reusable
TC, straight, pointed, DLC coating wavecut, 11.5 cm
Spiggle & Theis Medizintechnik GmbH
10-532-12WB
In Commercial Distribution

  • 04250676729071 ()
10-532-12WB

  • Ear scissors, reusable
TC, straight, pointed, DLC coating 11.5 cm
Spiggle & Theis Medizintechnik GmbH
10-532-12B
In Commercial Distribution

  • 04250676729064 ()
10-532-12B

  • Ear scissors, reusable
golden handle 2.5 mm, 18 cm
Spiggle & Theis Medizintechnik GmbH
20-425-25
In Commercial Distribution

  • 04250676732347 ()
20-425-25

  • 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
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
CO2 Oral-Nasal Cannula - Pediatric
Philips Medizin Systeme Böblingen GmbH
CO2 Oral-Nasal Cannula - Pediatric
Not in Commercial Distribution

  • 20884838072057 ()
  • 00884838072053 ()
989803144491

  • Nasal oxygen cannula, carbon-dioxide-sampling
CO2 Nasal Cannula - Pediatric
Philips Medizin Systeme Böblingen GmbH
CO2 Nasal Cannula - Pediatric
Not in Commercial Distribution

  • 20884838072002 ()
  • 00884838072008 ()
989803144431

  • Nasal oxygen cannula, carbon-dioxide-sampling
No Description
CHISON Medical Technologies Co., Ltd.
L10i-T
In Commercial Distribution

  • 06945121414272 ()
  • 06945121414418 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
CHISON Medical Technologies Co., Ltd.
L7R-T
In Commercial Distribution

  • 06945121414265 ()
  • 06945121414432 ()


  • Rectal/vaginal ultrasound imaging transducer
No Description
CHISON Medical Technologies Co., Ltd.
L18-T
In Commercial Distribution

  • 06945121414135 ()
  • 06945121414425 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
CHISON Medical Technologies Co., Ltd.
L12M-T
In Commercial Distribution

  • 06945121413527 ()
  • 06945121413541 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
Bien-Air Surgery SA
1502152
In Commercial Distribution

  • 27630055511007 ()
  • 17630055511000 ()
1502152-010

  • Suction/irrigation tubing, single-use
60° Multi-unit Abutment External Hex RP 8mm
Nobel Biocare AB
37775
In Commercial Distribution

  • 07332747089158 ()

  • Angle: 60.000 degree
  • Height: 8.000 Millimeter
37775

  • Dental implant suprastructure, permanent, preformed
60° Multi-unit Abutment External Hex RP 6mm
Nobel Biocare AB
37774
In Commercial Distribution

  • 07332747089141 ()

  • Angle: 60.000 degree
  • Height: 6.000 Millimeter
37774

  • Dental implant suprastructure, permanent, preformed
45° Multi-unit Abutment External Hex RP 6mm
Nobel Biocare AB
37624
In Commercial Distribution

  • 07332747086140 ()

  • Height: 6.000 Millimeter
  • Angle: 45.000 degree
37624

  • Dental implant suprastructure, permanent, preformed
45° Multi-unit Abutment External Hex RP 8mm
Nobel Biocare AB
37625
In Commercial Distribution

  • 07332747086133 ()

  • Height: 8.000 Millimeter
  • Angle: 45.000 degree
37625

  • Dental implant suprastructure, permanent, preformed
45° Multi-unit Abutment External Hex RP 10mm
Nobel Biocare AB
37626
In Commercial Distribution

  • 07332747086126 ()

  • Height: 10.000 Millimeter
  • Angle: 45.000 degree
37626

  • Dental implant suprastructure, permanent, preformed
60° Multi-unit Abutment External Hex RP 8mm
Nobel Biocare AB
37775
In Commercial Distribution

  • 07332747190960 ()

  • Angle: 60.000 degree
  • Height: 8.000 Millimeter
37775

  • Dental implant suprastructure, permanent, preformed
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