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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CUSTOM PACK CB7F84R3 3/16 E
MEDTRONIC, INC.
CB7F84R3
In Commercial Distribution

  • 00643169119185 ()


  • Cardiopulmonary bypass system blood tubing set
GUIDE X1011081 MIDLINE TEMPLATE E 23
MEDTRONIC SOFAMOR DANEK, INC.
X1011081
In Commercial Distribution

  • 00643169107557 ()


  • Surgical implant template, reusable
GUIDE X1011080 MIDLINE TEMPLATE E 21
MEDTRONIC SOFAMOR DANEK, INC.
X1011080
In Commercial Distribution

  • 00643169107540 ()


  • Surgical implant template, reusable
GUIDE X1011079 MIDLINE TEMPLATE E 19
MEDTRONIC SOFAMOR DANEK, INC.
X1011079
In Commercial Distribution

  • 00643169107533 ()


  • Surgical implant template, reusable
CUSTOM PACK HY8V48R FRSN HRT E
MEDTRONIC, INC.
HY8V48R
Not in Commercial Distribution

  • 00643169629622 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB5L90R18 PED E SU
MEDTRONIC, INC.
CB5L90R18
Not in Commercial Distribution

  • 00643169606807 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY1C44R18 1/4 E
MEDTRONIC, INC.
HY1C44R18
Not in Commercial Distribution

  • 00643169596351 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB8A17R1 PEDS E PK
MEDTRONIC, INC.
CB8A17R1
Not in Commercial Distribution

  • 00643169591233 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 7J94R 5PK E PRIME
MEDTRONIC, INC.
7J94R
In Commercial Distribution

  • 20643169183579 ()
  • 00643169183575 ()


  • Cardiopulmonary bypass system blood tubing set
E FOR M PERCEPTOR CABLE 12'
NAVILYST MEDICAL, INC.
70041201
In Commercial Distribution

  • H965700412010 ()

  • Length: 12 Feet


  • Invasive-pressure external transducer, single-use
CUSTOM PACK CB6Y34R4 1/4 E
MEDTRONIC, INC.
CB6Y34R4
Not in Commercial Distribution

  • 00643169229082 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 7T88R ADLT E NC
MEDTRONIC, INC.
7T88R
In Commercial Distribution

  • 00643169276734 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL7U43R6 3/8 E
MEDTRONIC, INC.
TL7U43R6
Not in Commercial Distribution

  • 00643169572768 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB7U79R9 3/8 E
MEDTRONIC, INC.
CB7U79R9
Not in Commercial Distribution

  • 00643169555518 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB7B33R5 ADT E H
MEDTRONIC, INC.
CB7B33R5
Not in Commercial Distribution

  • 00643169487437 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY7N00R3 E 3/8
MEDTRONIC, INC.
HY7N00R3
Not in Commercial Distribution

  • 00643169477117 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY7U24R3 P1/4 E
MEDTRONIC, INC.
HY7U24R3
Not in Commercial Distribution

  • 00643169493803 ()


  • Cardiopulmonary bypass system blood tubing set
ST INFINITY H&E STAINING SYSTEM
Leica Biosystems Richmond, Inc.
000000000003801698
In Commercial Distribution

  • 00849832027171 ()

  • Device Size Text, specify:


  • Biological stain IVD
HISTOCORE SPECTRA H&E STAINING S3-800
Leica Biosystems Richmond, Inc.
3801659
In Commercial Distribution

  • 00849832021308 ()

  • Device Size Text, specify:
3801659

  • Biological stain IVD
CUSTOM PACK HY7M07R5 E 1/4
MEDTRONIC, INC.
HY7M07R5
Not in Commercial Distribution

  • 00643169469051 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB6S20R9 1/4 E
MEDTRONIC, INC.
CB6S20R9
Not in Commercial Distribution

  • 00643169467095 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB8F93R1 5PK E SUPPORT
MEDTRONIC, INC.
CB8F93R1
Not in Commercial Distribution

  • 20643169462568 ()
  • 00643169462564 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 8E67R1 10PK E BRIDGE
MEDTRONIC, INC.
8E67R1
In Commercial Distribution

  • 20643169457342 ()
  • 00643169457348 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 8E65R 5PK PERF / E.
MEDTRONIC, INC.
8E65R
Not in Commercial Distribution

  • 20643169455874 ()
  • 00643169455870 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL7U43R5 3/8 E
MEDTRONIC, INC.
TL7U43R5
Not in Commercial Distribution

  • 00643169433878 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB9F93R2 PEDS E PK
MEDTRONIC, INC.
CB9F93R2
In Commercial Distribution

  • 00643169744738 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB8T53R3 PEDS E PK
MEDTRONIC, INC.
CB8T53R3
Not in Commercial Distribution

  • 00643169741157 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB8W77R ADULT E PK
MEDTRONIC, INC.
CB8W77R
Not in Commercial Distribution

  • 00643169724440 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB8T53R2 PEDS E PK
MEDTRONIC, INC.
CB8T53R2
Not in Commercial Distribution

  • 00643169724433 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL7U43R7 3/8 E
MEDTRONIC, INC.
TL7U43R7
Not in Commercial Distribution

  • 00643169718395 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY8V48R1 FRN HRT E
MEDTRONIC, INC.
HY8V48R1
Not in Commercial Distribution

  • 00643169675582 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB7U79R6 3/8 E
MEDTRONIC, INC.
CB7U79R6
Not in Commercial Distribution

  • 00643169349445 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB8A17R PEDS E PK
MEDTRONIC, INC.
CB8A17R
Not in Commercial Distribution

  • 00643169408630 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY7N00R4 E 3/8
MEDTRONIC, INC.
HY7N00R4
In Commercial Distribution

  • 00643169981119 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY7M07R6 E 1/4
MEDTRONIC, INC.
HY7M07R6
In Commercial Distribution

  • 00643169981102 ()


  • Cardiopulmonary bypass system blood tubing set
E/T TUBE CUFFED 2.5mm 10FR
SUNMED, LLC
1-7333-25
In Commercial Distribution

  • 20889483048105 ()
  • 10889483048108 ()

  • Length: 150 Millimeter
  • Outer Diameter: 3.33 Millimeter
  • Lumen/Inner Diameter: 2.5 Millimeter


  • Basic endotracheal tube, single-use
REINFORCED E/T TUBE CUFFED 32FR
SUNMED, LLC
1-7363-80
In Commercial Distribution

  • 20889483041090 ()
  • 10889483041093 ()

  • Length: 330 Millimeter
  • Outer Diameter: 10.67 Millimeter
  • Lumen/Inner Diameter: 8 Millimeter


  • Basic endotracheal tube, single-use
REINFORCED E/T TUBE CUFFED 28FR
SUNMED, LLC
1-7363-70
In Commercial Distribution

  • 20889483041076 ()
  • 10889483041079 ()

  • Length: 310 Millimeter
  • Outer Diameter: 9.33 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter


  • Basic endotracheal tube, single-use
REINFORCED E/T TUBED CUFFED 14FR
SUNMED, LLC
1-7363-35
In Commercial Distribution

  • 20889483041007 ()
  • 10889483041000 ()

  • Length: 185 Millimeter
  • Outer Diameter: 4.67 Millimeter
  • Lumen/Inner Diameter: 3.5 Millimeter


  • Basic endotracheal tube, single-use
E/T TUBE NO-CUFF 7.0mm 28FR
SUNMED, LLC
1-7330-70
In Commercial Distribution

  • 20889483021139 ()
  • 10889483021132 ()

  • Length: 310 Millimeter
  • Outer Diameter: 9.33 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter


  • Basic endotracheal tube, single-use
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