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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MSB BEDSIDE TRAY
MEDLINE INDUSTRIES, INC.
DYNJ54670A
In Commercial Distribution

  • 40195327653423 ()
  • 10195327653422 ()
DYNJ54670A

  • General surgical procedure kit, medicated
MSB BEDSIDE TRAY
MEDLINE INDUSTRIES, INC.
DYNJ54670
In Commercial Distribution

  • 10889942499571 ()
  • 40889942499572 ()
DYNJ54670

  • General surgical procedure kit, medicated
ADAPTER 6475010 MSB POWER
MEDTRONIC SOFAMOR DANEK, INC.
6475010
In Commercial Distribution

  • 00613994748102 ()


  • Basic power supply, reusable
BOVIE SPECIALIST MACH. PLUG TIP & BUSHING
GRACE MANUFACTURING, INC.
72000-08
In Commercial Distribution

  • 10801334012830 ()
MSB

  • Electrical-only medical device connection cable, reprocessed
3C SherpaCool Ribbons
Paragonix Technologies Inc
SHRP-1001-002
In Commercial Distribution

  • 00850005470649 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 32mm
Paragonix Technologies Inc
SHRP-1001-000-004
In Commercial Distribution

  • 00869582000385 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 25.4mm
Paragonix Technologies Inc
SHRP-1001-000-003
In Commercial Distribution

  • 00869582000378 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 18mm
Paragonix Technologies Inc
SHRP-1001-000-002
In Commercial Distribution

  • 00869582000361 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System HC 10mm
Paragonix Technologies Inc
SHRP-1001-000-001
In Commercial Distribution

  • 00869582000354 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Cardiac Transport System Canister Ships with 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1)
Paragonix Technologies Inc
SHRP-1001
In Commercial Distribution

  • 00869582000347 ()
  • 00869582000309 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak Heart Connector Box Contains 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1)
Paragonix Technologies Inc
SHRP-1001-003
Not in Commercial Distribution

  • 00869582000330 ()


  • General-purpose donor-organ preservation/transport system
Paragonix SherpaPak CTS Shipper Base
Paragonix Technologies Inc
SHRP-1001-001
In Commercial Distribution

  • 10869582000313 ()
  • 00869582000316 ()
  • 20869582000310 ()
  • 00850005470267 ()


  • General-purpose donor-organ preservation/transport system
Sterile, non-pyrogenic cold flush, storage and transport solution for Hearts.
INSTITUT GEORGES LOPEZ
CELSIOR 1L US
In Commercial Distribution

  • 13700911900126 ()
  • 23700911900123 ()
533682

  • Donor-organ/tissue/cell preservation solution
Servator H Solution is intended for flushing and cold storage of abdominal organs at the time of removal from the donor in preparation fort storage, transportation, and the eventual transplantation into a recipient.
GLOBAL TRANSPLANT SOLUTIONS, INC.
GTS-SERV-HTK-5000
In Commercial Distribution

  • 00851983008060 ()


  • Kidney donor-organ preservation/transport perfusion set
SherapaPak SherpaCool Ribbons and Pouch
Paragonix Technologies Inc
SHRP-1001-002
In Commercial Distribution

  • 10850005470271 ()
  • 20850005470278 ()


  • General-purpose donor-organ preservation/transport system
OCS Lung Donor Flush Set
TRANSMEDICS, INC.
2406
In Commercial Distribution

  • B00958755 ()
  • B00958753 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2406

  • Donor-organ preservation/transport perfusion initiation/termination set
ENT Dilation System 6x8mm
STRYKER CORPORATION
MSB
Not in Commercial Distribution

  • 00857326005079 ()
JD-206

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use
ENT Dilation System 7x18mm
STRYKER CORPORATION
MSB
Not in Commercial Distribution

  • 00857326005062 ()
JD-107

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use
ENT Dilation System 6x18mm
STRYKER CORPORATION
MSB
Not in Commercial Distribution

  • 00857326005055 ()
  • 10857326005052 ()
JD-106

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use
3 ml of 0.85% Sterile Normal Saline in screw-cap tube, with nasopharyngeal swab.
Shenzhen Dakewe Bio-engineering Co., Ltd
MSB
In Commercial Distribution

  • 06973471960729 ()


  • General tissue specimen container IVD, fixative/saline
3 ml of 0.85% Biosci™ Sterile Normal Saline in screw-cap tube, with nasopharyngeal swab.
Shenzhen Dakewe Bio-engineering Co., Ltd
MSB
In Commercial Distribution

  • 06973471960705 ()


  • General tissue specimen container IVD, fixative/saline
SCREW 8437550 DYLC BOLT 7.5X50 TI
MEDTRONIC SOFAMOR DANEK, INC.
8437550
In Commercial Distribution

  • 00673978950525 ()

  • 7.5mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8437545 DYLC BOLT 7.5X45 TI
MEDTRONIC SOFAMOR DANEK, INC.
8437545
In Commercial Distribution

  • 00673978950518 ()

  • 7.5mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8437540 DYLC BOLT 7.5X40 TI
MEDTRONIC SOFAMOR DANEK, INC.
8437540
In Commercial Distribution

  • 00673978950501 ()

  • 7.5mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8437050 DYLC BOLT 7.0X50 TI
MEDTRONIC SOFAMOR DANEK, INC.
8437050
In Commercial Distribution

  • 00673978950426 ()

  • 7.0mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8437045 DYLC BOLT 7.0X45 TI
MEDTRONIC SOFAMOR DANEK, INC.
8437045
In Commercial Distribution

  • 00673978950419 ()

  • 7.0mm


  • Orthopaedic bone screw (non-sliding)
SCREW 8437040 DYLC BOLT 7.0X40 TI
MEDTRONIC SOFAMOR DANEK, INC.
8437040
In Commercial Distribution

  • 00673978950402 ()

  • 7.0mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8437035 DYLC BOLT 7.0X35 TI
MEDTRONIC SOFAMOR DANEK, INC.
8437035
In Commercial Distribution

  • 00673978950396 ()

  • 7.0mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8436550 DYLC BOLT 6.5X50 TI
MEDTRONIC SOFAMOR DANEK, INC.
8436550
Not in Commercial Distribution

  • 00673978950372 ()

  • 6.5mm


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
SCREW 8436545 DYLC BOLT 6.5X45 TI
MEDTRONIC SOFAMOR DANEK, INC.
8436545
In Commercial Distribution

  • 00673978950365 ()

  • 6.5mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8436540 DYLC BOLT 6.5X40 TI
MEDTRONIC SOFAMOR DANEK, INC.
8436540
In Commercial Distribution

  • 00673978950358 ()

  • 6.5mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8436535 DYLC BOLT 6.5X35 TI
MEDTRONIC SOFAMOR DANEK, INC.
8436535
In Commercial Distribution

  • 00673978950341 ()

  • 6.5mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8435545 DYLC BOLT 5.5X45 TI
MEDTRONIC SOFAMOR DANEK, INC.
8435545
In Commercial Distribution

  • 00673978950303 ()

  • 5.5mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8435540 DYLC BOLT 5.5X40 TI
MEDTRONIC SOFAMOR DANEK, INC.
8435540
In Commercial Distribution

  • 00673978950297 ()

  • 5.5mm


  • Spinal bone screw, non-bioabsorbable
SCREW 8435005 DY CLASSIC WASHER NUTTI
MEDTRONIC SOFAMOR DANEK, INC.
8435005
In Commercial Distribution

  • 00673978950259 ()


  • Spinal bone screw, non-bioabsorbable
UNIT ROD 6.35X27CM SS
MEDTRONIC SOFAMOR DANEK, INC.
X830-527
Not in Commercial Distribution

  • 00673978159713 ()

  • DIA=5.5mm x 27cm


  • Bone-screw internal spinal fixation system rod
UNIT ROD 6.35X29CM SS
MEDTRONIC SOFAMOR DANEK, INC.
X830-029
Not in Commercial Distribution

  • 00673978159706 ()

  • DIA=1/4in (6.35mm) x 29cm


  • Bone-screw internal spinal fixation system rod
SCREW C374L70 CDH SAC BLK 7.0X70
MEDTRONIC SOFAMOR DANEK, INC.
C374L70
In Commercial Distribution

  • 00673978109701 ()

  • Length: 70.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW C374L60 CDH SAC BLK 7.0X60
MEDTRONIC SOFAMOR DANEK, INC.
C374L60
In Commercial Distribution

  • 00673978109664 ()

  • Outer Diameter: 7.0 Millimeter
  • Length: 60.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW C374L50 CDH SAC BLK 7.0X50
MEDTRONIC SOFAMOR DANEK, INC.
C374L50
In Commercial Distribution

  • 00673978109626 ()

  • Length: 50.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW C374L40 CDH SAC BLK 7.0X40
MEDTRONIC SOFAMOR DANEK, INC.
C374L40
In Commercial Distribution

  • 00673978109589 ()

  • Length: 40.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW C374L35 CDH SAC BLK 7.0X35
MEDTRONIC SOFAMOR DANEK, INC.
C374L35
In Commercial Distribution

  • 00673978109565 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
INSTRUMENT 6246064 16X14 RASP
MEDTRONIC SOFAMOR DANEK, INC.
6246064
In Commercial Distribution

  • 00763000867904 ()


  • Metallic spinal interbody fusion cage
AWL 9870004 3.5 X 20MM
MEDTRONIC SOFAMOR DANEK, INC.
9870004
In Commercial Distribution

  • 00763000679408 ()


  • Bone awl, reusable
OCS Lung Solution
TRANSMEDICS, INC.
2300
In Commercial Distribution

  • B00944671 ()
  • B00944670 ()

  • Height: 2.5 Inch
  • Width: 5.5 Inch
  • Length: 14 Inch
2300

  • Donor-organ/tissue/cell preservation solution
ENT Dilation System 6x8mm
STRYKER CORPORATION
MSB&LLF
In Commercial Distribution

  • 00857326005147 ()
  • 10857326005144 ()
ULF-206

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use
ENT Dilation System 5x8mm
STRYKER CORPORATION
MSB&LLF
In Commercial Distribution

  • 00857326005130 ()
  • 10857326005137 ()
ULF-205

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use
ENT Dilation System 6x20mm
STRYKER CORPORATION
MSB&LLF
In Commercial Distribution

  • 00857326005123 ()
  • 10857326005120 ()
ULF-106

  • Eustachian catheter, single-use
  • Nasal/paranasal balloon catheter
ENT Dilation System 5x20mm
STRYKER CORPORATION
MSB&LLF
In Commercial Distribution

  • 00857326005116 ()
  • 10857326005113 ()
ULF-105

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use
ENT Dilation System 6x8mm
STRYKER CORPORATION
MSB&LLF
In Commercial Distribution

  • 00857326005048 ()
  • 10857326005045 ()
LPLF-206

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use
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