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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L-BONE PLATE, LEFT, WITH BAR
Stryker Leibinger GmbH & Co. KG
54-05135
In Commercial Distribution

  • 04546540238108 ()

  • Number of Screw Holes: 4.0 Holes
  • Bar Length: 4.4 Millimeter
54-05135

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
BONE PLATE, WITH BAR
Stryker Leibinger GmbH & Co. KG
54-05106
In Commercial Distribution

  • 04546540237989 ()

  • Bar Length: 4.4 Millimeter
  • Number of Screw Holes: 4.0 Holes
54-05106

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DYNAMIC MESH STD F. 2.0MM SCREWS
Stryker Leibinger GmbH & Co. KG
54-00653
In Commercial Distribution

  • 04546540237682 ()

  • Length: 20.0 Centimeter
  • Thickness: 0.6 Millimeter
  • Width: 20.0 Centimeter
  • Length: 200.0 Millimeter
  • Width: 200.0 Millimeter
54-00653

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DYNAMIC MESH STD F. 2.0MM SCREWS
Stryker Leibinger GmbH & Co. KG
54-00650
In Commercial Distribution

  • 04546540237675 ()

  • Length: 9.0 Centimeter
  • Width: 9.0 Centimeter
  • Thickness: 0.6 Millimeter
  • Length: 90.0 Millimeter
  • Width: 90.0 Millimeter
54-00650

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DYNAMIC MESH STD F. 1.5/1.7MM SCREWS
Stryker Leibinger GmbH & Co. KG
54-00647
In Commercial Distribution

  • 04546540237668 ()

  • Thickness: 0.6 Millimeter
  • Width: 200.0 Millimeter
  • Length: 200.0 Millimeter
54-00647

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DYNAMIC MESH STD F. 1.0/1.2MM SCREWS
Stryker Leibinger GmbH & Co. KG
54-00642
In Commercial Distribution

  • 04546540237644 ()

  • Length: 9.0 Centimeter
  • Width: 9.0 Centimeter
  • Thickness: 0.6 Millimeter
  • Width: 90.0 Millimeter
  • Length: 90.0 Millimeter
54-00642

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DYNAMIC MESH MALL. F. 2.0MM SCREWS
Stryker Leibinger GmbH & Co. KG
54-00350
In Commercial Distribution

  • 04546540237620 ()

  • Thickness: 0.3 Millimeter
  • Length: 9.0 Centimeter
  • Width: 9.0 Centimeter
  • Width: 90.0 Millimeter
  • Length: 90.0 Millimeter
54-00350

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Micro Mesh
Stryker Leibinger GmbH & Co. KG
54-00272
In Commercial Distribution

  • 04546540237569 ()

  • Thickness: 0.2 Millimeter
  • Length: 60.0 Millimeter
  • Width: 60.0 Millimeter
54-00272

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MICRO MESH
Stryker Leibinger GmbH & Co. KG
54-00270
In Commercial Distribution

  • 04546540237545 ()

  • Thickness: 0.2 Millimeter
  • Length: 12.0 Centimeter
  • Width: 12.0 Centimeter
  • Width: 120.0 Millimeter
  • Length: 120.0 Millimeter
54-00270

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Micro Mesh
Stryker Leibinger GmbH & Co. KG
54-00262
In Commercial Distribution

  • 04546540237538 ()

  • Thickness: 0.1 Millimeter
  • Width: 60.0 Millimeter
  • Length: 60.0 Millimeter
54-00262

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MICRO MESH
Stryker Leibinger GmbH & Co. KG
54-00260
In Commercial Distribution

  • 04546540237514 ()

  • Thickness: 0.1 Millimeter
  • Length: 12.0 Centimeter
  • Width: 12.0 Centimeter
  • Width: 120.0 Millimeter
  • Length: 120.0 Millimeter
54-00260

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
292-022-000
In Commercial Distribution

  • 09348215018054 ()


  • Surgical mallet
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
292-022-111
In Commercial Distribution

  • 09348215018030 ()


  • Surgical mallet
N/A
Cochlear Bone Anchored Solutions AB
90459
In Commercial Distribution

  • 09321502040129 ()

  • Length: 20 Millimeter
  • 20 mm long screwdriver
90459

  • Surgical screwdriver, reusable
Machine Screwdriver 20mm UniGrip
Cochlear Bone Anchored Solutions AB
90380
In Commercial Distribution

  • 09321502040082 ()

  • 20 mm screwdriver
  • Length: 20 Millimeter
90380

  • Surgical screwdriver, reusable
Screwdriver Shaft, Ball-Tipped 3,5 mm
Stryker GmbH
1806-0300
In Commercial Distribution

  • 04546540196378 ()
1806-0300

  • Surgical screwdriver, reusable
Screwdriver, Condyle Screw
Stryker GmbH
1806-0255
In Commercial Distribution

  • 04546540196323 ()
1806-0255

  • Surgical screwdriver, reusable
Slotted Hammer
Stryker GmbH
1806-0170
In Commercial Distribution

  • 04546540196118 ()
1806-0170

  • Surgical mallet
230V Autopsy Saw
STRYKER CORPORATION
0811000000
Not in Commercial Distribution

  • 04546540178237 ()
0811-000-000

  • Surgical mallet
QUIK FLAP SET, SQUARE-FIT
Stryker Leibinger GmbH & Co. KG
12-01110
Not in Commercial Distribution

  • 04546540174680 ()
12-01110

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Finishing Driver, Double-Ended
Stryker GmbH
07-40202
In Commercial Distribution

  • 04546540156259 ()

  • Length: 15.5 Centimeter
07-40202

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Screwdriver Baha
Cochlear Bone Anchored Solutions AB
HIB 003-0
In Commercial Distribution

  • 09321502040150 ()
HIB 003-0

  • Surgical screwdriver, reusable
N/A
Cochlear Bone Anchored Solutions AB
90456
In Commercial Distribution

  • 09321502040112 ()

  • 17 mm long screwdriver
  • Length: 17 Millimeter
90456

  • Surgical screwdriver, reusable
Screwdriver for hexagon
Cochlear Bone Anchored Solutions AB
90408
In Commercial Distribution

  • 09321502040099 ()
90408

  • Surgical screwdriver, reusable
MEDRAD® Centargo CT Injection System
IMAXEON PTY LTD
CENT-SYS-BAT
In Commercial Distribution

  • 09345390003349 ()
CENT-SYS-BAT

  • CT contrast medium injection system, line-powered, mobile
ASSY,MODULE,ISI2,CORE (89302900)
Bayer Medical Care Inc.
ISI2
In Commercial Distribution

  • 00616258027340 ()
ISI2

  • CT contrast medium injection system, line-powered, mobile
MAINTAINER,SYR HEAT,STEL,PFS,LR (88457285)
BAYER MEDICAL CARE INC.
SSH 100F
In Commercial Distribution

  • 00616258026473 ()
SSH 100F

  • CT contrast medium injection system, line-powered, mobile
MAINTAIN,SYR HEAT,STELL,FLS2,LR (87980030)
BAYER MEDICAL CARE INC.
SSH 200F
In Commercial Distribution

  • 00616258025384 ()
SSH 200F

  • CT contrast medium injection system, line-powered, mobile
No Description
Bayer Medical Care Inc.
SCT-310, SCT-321, SCT-322
In Commercial Distribution

  • 00616258025131 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
SYSTEM,INJECTOR,MRXPERION,CORE,LR (87838420)
Bayer Medical Care Inc.
MRXP 200
In Commercial Distribution

MRXP 200

  • MRI contrast medium injection system, line-powered, mobile
ASSY, Module, ISI2 (86882302)
Bayer Medical Care Inc.
ISI2
In Commercial Distribution

  • 00616258022512 ()
ISI2

  • CT contrast medium injection system, line-powered, mobile
SYSTEM,INJECTOR,MRXPERION (86410036)
BAYER MEDICAL CARE INC.
MRXperion
In Commercial Distribution

  • 00616258021355 ()
MRXP 200

  • MRI contrast medium injection system, line-powered, mobile
CT – STELLANT D DUAL INJECTOR, UPGRADED (86184524)
BAYER MEDICAL CARE INC.
Stellant D
In Commercial Distribution

  • 00616258021348 ()
SCT-210, SCT-211, SCT-212, SCT-221, SCT-222

  • CT contrast medium injection system, line-powered, mobile
DUAL,STELLANT W/CERTEGRA WKS, UPGRADED (86184516)
BAYER MEDICAL CARE INC.
Stellant D-CE
In Commercial Distribution

  • 00616258021331 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
STELLANT,SYS,INJ,D SYR,W/CERT WKS,MC,4ED (85937286)
BAYER MEDICAL CARE INC.
Stellant D-CE
In Commercial Distribution

  • 00616258020860 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
STELLANT,SYS,INJ,D,DUAL SYR,LATAM2,4ED (85920278)
BAYER MEDICAL CARE INC.
Stellant D-CE
In Commercial Distribution

  • 00616258020822 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
SYSTEM,DUAL,STELLANT,REMANUFACTURED,FLEX (85631829)
BAYER MEDICAL CARE INC.
Stellant FLEX
In Commercial Distribution

  • 00616258020792 ()
FLEX UPG

  • CT contrast medium injection system, line-powered, mobile
MAINTAIN,SYR HEAT,STEL,FLS2,UDI,BATCH,JA (85864483)
BAYER MEDICAL CARE INC.
SSH 200F
In Commercial Distribution

  • 00616258020662 ()
SSH 200F

  • CT contrast medium injection system, line-powered, mobile
SYSTEM,DUAL,STELLANT,FLEX (85577026)
BAYER MEDICAL CARE INC.
Stellant FLEX
In Commercial Distribution

  • 00616258011219 ()
FLEX

  • CT contrast medium injection system, line-powered, mobile
REFURBISHED SYSTEM,SNGL SYR,STELLANT SX (84856798)
BAYER MEDICAL CARE INC.
SCT121-R, SCT122-R
In Commercial Distribution

  • 00616258010588 ()
SCT121-R, SCT122-R

  • CT contrast medium injection system, line-powered, mobile
REFURBISHED SYSTEM,DUAL SYR,STELLANT D (59875705)
BAYER MEDICAL CARE INC.
SCT211-R, SCT212-R, SCT221-R, SCT222-R
In Commercial Distribution

  • 00616258010571 ()
SCT211-R, SCT212-R, SCT221-R, SCT222-R

  • CT contrast medium injection system, line-powered, mobile
CABLE,HANDSWITCH,20',DCU,UDI,BATCH (85594389)
BAYER MEDICAL CARE INC.
EDS 700 20
In Commercial Distribution

  • 00616258010519 ()
EDS 700 20

  • CT contrast medium injection system, line-powered, mobile
ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH (85594370)
BAYER MEDICAL CARE INC.
RPA 550-1
In Commercial Distribution

  • 00616258010502 ()
RPA 550-1

  • CT contrast medium injection system, line-powered, mobile
CABLE,HANDSWITCH,5',DCU,UDI,BATCH (85594281)
BAYER MEDICAL CARE INC.
EDS 700 05
In Commercial Distribution

  • 00616258010472 ()
EDS 700 05

  • CT contrast medium injection system, line-powered, mobile
CABLE,START SWITCH,25FT,4PIN,UDI,BATCH (85594168)
BAYER MEDICAL CARE INC.
RPA 550
In Commercial Distribution

  • 00616258010441 ()
RPA 550

  • CT contrast medium injection system, line-powered, mobile
MAINTAINER,HEAT,SYR,125/200 ML,UDI,BATCH (85594133)
BAYER MEDICAL CARE INC.
VSH 600
In Commercial Distribution

  • 00616258010427 ()
VSH 600

  • CT contrast medium injection system, line-powered, mobile
CBL,HANDSWITCH,20',HEAD,MCT2.0,UDI,BATCH (85591312)
BAYER MEDICAL CARE INC.
EHS 700 20
In Commercial Distribution

  • 00616258010410 ()
EHS 700 20

  • CT contrast medium injection system, line-powered, mobile
CBL,HANDSWITCH,5',HEAD,MCT2.0,UDI,BATCH (85591304)
BAYER MEDICAL CARE INC.
EHS 700 05
In Commercial Distribution

  • 00616258010403 ()
EHS 700 05

  • CT contrast medium injection system, line-powered, mobile
MAINTAIN,SYRINGE HEAT,ENVISION,UDI,BATCH (85591290)
BAYER MEDICAL CARE INC.
ESH 700
In Commercial Distribution

  • 00616258010397 ()
ESH 700

  • CT contrast medium injection system, line-powered, mobile
SYSTEM,DUAL,STELLANT D,COUNTRY SPECIFIC (85077198)
BAYER MEDICAL CARE INC.
Stellant D
In Commercial Distribution

  • 00616258010250 ()
SCT-210, SCT-211, SCT-212, SCT-221, SCT-222

  • CT contrast medium injection system, line-powered, mobile
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