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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MON 2020B2 CARELINK USA MR4 MONITOR
MEDTRONIC, INC.
2020B2
Not in Commercial Distribution

  • 00643169107052 ()


  • Cardiac pulse generator reader, home-use
INSTRUMENT KIT PFF0001 FACET FIXATION
MEDTRONIC SOFAMOR DANEK, INC.
PFF0001
In Commercial Distribution

  • 00643169099432 ()


  • Neurosurgical curette, single-use
LIT 3330L DYSTONIA 37603
MEDTRONIC, INC.
3330
In Commercial Distribution

  • 00643169091153 ()


  • Deep brain electrical stimulation system
LIT 3320L DYSTONIA 37602 INS
MEDTRONIC, INC.
3320
In Commercial Distribution

  • 00643169091146 ()


  • Deep brain electrical stimulation system
LIT 3310L DYSTONIA 37601 INS
MEDTRONIC, INC.
3310
In Commercial Distribution

  • 00643169091115 ()


  • Deep brain electrical stimulation system
CASE 7059532L LEG STND HK MOD LID TI
MEDTRONIC SOFAMOR DANEK, INC.
7059532L
In Commercial Distribution

  • 00721902957123 ()


  • Instrument tray, reusable
CASE 7059532 LEG STANDARD HOOK MOD TI
MEDTRONIC SOFAMOR DANEK, INC.
7059532
In Commercial Distribution

  • 00721902957093 ()


  • Instrument tray, reusable
PRGM 2090AA4 PORTABLECRM
MEDTRONIC, INC.
2090AA4
Not in Commercial Distribution

  • 00721902824692 ()


  • Cardiac pulse generator programmer
Inflation Device Atrion Part Number 96473: 14mL, 30atm
ATRION MEDICAL PRODUCTS, INC.
QL1430
In Commercial Distribution

  • 00856877002469 ()
96473

  • Catheter/overtube balloon inflator, single-use
Inflation Device: 8mL, 30atm
ATRION MEDICAL PRODUCTS, INC.
QL830
In Commercial Distribution

  • 00856877002186 ()
96491

  • Catheter/overtube balloon inflator, single-use
SIZER SET 578 OPHV AP-AP360 NITINOL26LCE
MEDTRONIC, INC.
578
In Commercial Distribution

  • 00763000318604 ()

  • 16-28 mm


  • Heart valve annulus sizer, reusable
SIZER SET 577 OPHV STANDARD 26L CE
MEDTRONIC, INC.
577
In Commercial Distribution

  • 00763000318598 ()

  • 19-35 mm


  • Heart valve annulus sizer, reusable
HANDLE BENDABLE 569 OPHV 26L CE
MEDTRONIC, INC.
569
In Commercial Distribution

  • 00763000318581 ()


  • Heart valve prosthesis sizer handle
SIZER SET 576 OPHV NITINOL 26L CE
MEDTRONIC, INC.
576
In Commercial Distribution

  • 00763000318550 ()


  • Heart valve annulus sizer, reusable
LIT 3330L DYSTONIA 37603 DBS
MEDTRONIC, INC.
3330L
In Commercial Distribution

  • 00763000007614 ()


  • Deep brain electrical stimulation system
LIT 3319L DYSTONIA 37601 W/3389S DBS
MEDTRONIC, INC.
3319L
In Commercial Distribution

  • 00763000007591 ()


  • Deep brain electrical stimulation system
LIT 3317L DYSTONIA 37601 W/3387S DBS
MEDTRONIC, INC.
3317L
In Commercial Distribution

  • 00763000007584 ()


  • Deep brain electrical stimulation system
LIT 3339L DYSTONIA 37603 W/3389S DBS
MEDTRONIC, INC.
3339L
In Commercial Distribution

  • 00763000007638 ()


  • Deep brain electrical stimulation system
LIT 3337L DYSTONIA 37603 W/3387S DBS
MEDTRONIC, INC.
3337L
In Commercial Distribution

  • 00763000007621 ()


  • Deep brain electrical stimulation system
LIT 3320L DYSTONIA 37602 DBS
MEDTRONIC, INC.
3320L
In Commercial Distribution

  • 00763000007607 ()


  • Deep brain electrical stimulation system
LIT 3310L DYSTONIA 37601 DBS
MEDTRONIC, INC.
3310L
In Commercial Distribution

  • 00763000007577 ()


  • Deep brain electrical stimulation system
TRAY RBT090100 ROBOTIC GRAFT DELIVERY
MEDTRONIC SOFAMOR DANEK, INC.
RBT090100
In Commercial Distribution

  • 00763000761134 ()


  • Instrument tray, reusable
TRAY 5598920 LOCKING HEAD INSERTER LOWER
MEDTRONIC SOFAMOR DANEK, INC.
5598920
In Commercial Distribution

  • 00763000654573 ()


  • Instrument tray, reusable
TRAY 5598919 LOCKING HEAD INSERTER UPPER
MEDTRONIC SOFAMOR DANEK, INC.
5598919
In Commercial Distribution

  • 00763000654566 ()


  • Instrument tray, reusable
TRAY 5332041 GENERAL INSTRUMENTS LOWER
MEDTRONIC SOFAMOR DANEK, INC.
5332041
In Commercial Distribution

  • 00763000090999 ()


  • Instrument tray, reusable
TRAY 5332040 GENERAL INSTRUMENTS UPPER
MEDTRONIC SOFAMOR DANEK, INC.
5332040
In Commercial Distribution

  • 00763000090982 ()


  • Instrument tray, reusable
PROGRAMMER 2090W TELEMETRY C US
MEDTRONIC, INC.
2090W
In Commercial Distribution

  • 00885074301440 ()


  • Cardiac pulse generator programmer
CHARGER MMT-7715 MLNK GST3 21L RPL
MEDTRONIC MINIMED, INC.
MMT-7715
In Commercial Distribution

  • 00643169283183 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
KIT MMT-5101N SIMPLERA 5PK US
MEDTRONIC MINIMED, INC.
MMT-5101N
In Commercial Distribution

  • 00763000565046 ()
  • 20763000565040 ()


  • Percutaneous interstitial fluid glucose monitoring system sensor
SENSOR MMT-5100JB SIMPLERA 1PK US
MEDTRONIC MINIMED, INC.
MMT-5100JB
In Commercial Distribution

  • 00763000565039 ()


  • Percutaneous interstitial fluid glucose monitoring system sensor
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump/FloProbe Kit (Non-Sterile)
Not in Commercial Distribution

  • 00814321020452 ()
6000N(KIT)

  • Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
1/4" FloPump (Non-Sterile)
Not in Commercial Distribution

  • 00814321020124 ()
6300N

  • Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
1/4" FloPump (Sterile)
Not in Commercial Distribution

  • 00814321020117 ()
6300S

  • Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
1/4" FloPump/FloProbe Kit (Sterile)
Not in Commercial Distribution

  • 00814321020100 ()
6300S(KIT)

  • Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump/FloProbe Kit (Sterile)
Not in Commercial Distribution

  • 00814321020094 ()
6000S(KIT)

  • Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump (Sterile)
Not in Commercial Distribution

  • 00814321020018 ()
6000S

  • Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump (Non-Sterile)
Not in Commercial Distribution

  • 00814321020001 ()
6000N

  • Cardiopulmonary bypass system centrifugal pump
CUSTOM PACK 6B79R2 HEART
MEDTRONIC, INC.
6B79R2
Not in Commercial Distribution

  • 00613994591210 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB6C23R2 CCS PED
MEDTRONIC, INC.
CB6C23R2
Not in Commercial Distribution

  • 00613994590657 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 5X46R1 PIGTAILS
MEDTRONIC, INC.
5X46R1
Not in Commercial Distribution

  • 00613994577290 ()


  • Cardiopulmonary bypass system blood tubing set
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