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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NON-BRIDGING EXTERNAL FIXATOR SHOULDER
NUTEK ORTHOPAEDICS INC
8107-00-00
In Commercial Distribution

  • B488810700000 ()
8107-00-00

  • External orthopaedic fixation system, single-use, sterile
NON-BRIDGING EXTERNAL FIXATOR WRIST
NUTEK ORTHOPAEDICS INC
8006-00-00
In Commercial Distribution

  • B488800600000 ()
8006-00-00

  • External orthopaedic fixation system, single-use, sterile
Handle, AO, External, Non-ratcheting
Kalitec Direct LLC
01-K03-8001
In Commercial Distribution

  • B07301K0380010 ()
01-K03-8001

  • Surgical instrument handle, non-torque-limiting
External Sinus Lift System
Hager & Meisinger Gesellschaft mit beschränkter Haftung
BTL00
In Commercial Distribution

  • E0HM79BTL001 ()
BTL00

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
External Paddles - Water Resistant
Philips Medical Systems Hsg
External Paddles Water Resistant
In Commercial Distribution

  • 20884838015245 ()
M3543A

  • External defibrillation electrode, adult, reusable
External hexagon surgical kit
MIS Implants Technologies Ltd.
MK-0045
In Commercial Distribution

  • 07290109014050 ()
MK-0045

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Implant analog external hex.
MIS Implants Technologies Ltd.
ED-RSM10
Not in Commercial Distribution

  • 07290109015934 ()
ED-RSM10

  • Dental implant suprastructure, temporary, preformed, single-use
EXTERNAL HEXAGONAL SCREW EXTRACTOR
TELEFLEX INCORPORATED
IPN016617
In Commercial Distribution

  • 24026704606560 ()

  • Length: 2 Inch
OS100224

  • Screw extractor, reusable
TRUELOK ELEVATE EXTERNAL FIXATOR
ORTHOFIX SRL
1
In Commercial Distribution

  • 18059015375909 ()
50-2505

  • External orthopaedic fixation system, single-use
EXTERNAL ROTATION DRILL GUIDE
Smith & Nephew, Inc.
E0017139-7
In Commercial Distribution

  • 00885556794937 ()
E0017139-7

  • Surgical drill guide, reusable
EXTERNAL ROTATION DRILL GUIDE
Smith & Nephew, Inc.
E0017108-7
In Commercial Distribution

  • 00885556793695 ()
E0017108-7

  • Surgical drill guide, reusable
EXTERNAL STAIN KIT 73g
KURARAY NORITAKE DENTAL INC.
102-0220KA
In Commercial Distribution

  • EKUR1020220KA0 ()


  • Dental appliance fabrication material, ceramic
EXTERNAL ROTATION DRILL GUIDE
Smith & Nephew, Inc.
E0015467-7
In Commercial Distribution

  • 00885556694138 ()
E0015467-7

  • Surgical drill guide, reusable
AUTO EXTERNAL DEFIBRILLATION, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426074469 ()
  • 00748426074464 ()


  • Cardiopulmonary resuscitation kit, single-use
AUTO EXTERNAL DEFIBRILLATION, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426074407 ()
  • 00748426120383 ()


  • Cardiopulmonary resuscitation kit, single-use
EXTERNAL ROTATION DRILL GUIDE
Smith & Nephew, Inc.
E0018176-7
In Commercial Distribution

  • 00885556913796 ()
E0018176-7

  • Orthopaedic prosthesis implantation positioning instrument, reusable
External Stain Cervical3 3g
KURARAY NORITAKE DENTAL INC.
104-3581KA
In Commercial Distribution

  • EKUR1043581KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Cervical2 3g
KURARAY NORITAKE DENTAL INC.
104-3571KA
In Commercial Distribution

  • EKUR1043571KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Cervical1 3g
KURARAY NORITAKE DENTAL INC.
104-3561KA
In Commercial Distribution

  • EKUR1043561KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Yellow 3g
KURARAY NORITAKE DENTAL INC.
104-3551KA
In Commercial Distribution

  • EKUR1043551KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Orange2 3g
KURARAY NORITAKE DENTAL INC.
104-3541KA
In Commercial Distribution

  • EKUR1043541KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Orange1 3g
KURARAY NORITAKE DENTAL INC.
104-3531KA
In Commercial Distribution

  • EKUR1043531KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Green2 3g
KURARAY NORITAKE DENTAL INC.
104-3521KA
In Commercial Distribution

  • EKUR1043521KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Green1 3g
KURARAY NORITAKE DENTAL INC.
104-3511KA
In Commercial Distribution

  • EKUR1043511KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Blue 3g
KURARAY NORITAKE DENTAL INC.
104-3501KA
In Commercial Distribution

  • EKUR1043501KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Black 3g
KURARAY NORITAKE DENTAL INC.
104-3491KA
In Commercial Distribution

  • EKUR1043491KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Gray 3g
KURARAY NORITAKE DENTAL INC.
104-3471KA
In Commercial Distribution

  • EKUR1043471KA0 ()


  • Dental appliance fabrication material, ceramic
EXTERNAL STAIN KIT 73g
KURARAY NORITAKE DENTAL INC.
104-1820KA
In Commercial Distribution

  • EKUR1041820KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Glaze 10g
KURARAY NORITAKE DENTAL INC.
103-1511KA
In Commercial Distribution

  • EKUR1031511KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain D+ 3g
KURARAY NORITAKE DENTAL INC.
103-1501KA
In Commercial Distribution

  • EKUR1031501KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain C+ 3g
KURARAY NORITAKE DENTAL INC.
103-1491KA
In Commercial Distribution

  • EKUR1031491KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
103-1481KA
In Commercial Distribution

  • EKUR1031481KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain A+ 3g
KURARAY NORITAKE DENTAL INC.
103-1471KA
In Commercial Distribution

  • EKUR1031471KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Red 3g
KURARAY NORITAKE DENTAL INC.
103-1461KA
In Commercial Distribution

  • EKUR1031461KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Pink 3g
KURARAY NORITAKE DENTAL INC.
103-1451KA
In Commercial Distribution

  • EKUR1031451KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Cervical3 3g
KURARAY NORITAKE DENTAL INC.
103-1411KA
In Commercial Distribution

  • EKUR1031411KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Cervical2 3g
KURARAY NORITAKE DENTAL INC.
103-1401KA
In Commercial Distribution

  • EKUR1031401KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Cervical1 3g
KURARAY NORITAKE DENTAL INC.
103-1391KA
In Commercial Distribution

  • EKUR1031391KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Yellow 3g
KURARAY NORITAKE DENTAL INC.
103-1381KA
In Commercial Distribution

  • EKUR1031381KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Orange-2 3g
KURARAY NORITAKE DENTAL INC.
103-1371KA
In Commercial Distribution

  • EKUR1031371KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Orange-1 3g
KURARAY NORITAKE DENTAL INC.
103-1361KA
In Commercial Distribution

  • EKUR1031361KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Green-2 3g
KURARAY NORITAKE DENTAL INC.
103-1351KA
In Commercial Distribution

  • EKUR1031351KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Green-1 3g
KURARAY NORITAKE DENTAL INC.
103-1341KA
In Commercial Distribution

  • EKUR1031341KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Blue 3g
KURARAY NORITAKE DENTAL INC.
103-1331KA
In Commercial Distribution

  • EKUR1031331KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Black 3g
KURARAY NORITAKE DENTAL INC.
103-1321KA
In Commercial Distribution

  • EKUR1031321KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Gray 3g
KURARAY NORITAKE DENTAL INC.
103-1301KA
In Commercial Distribution

  • EKUR1031301KA0 ()


  • Dental appliance fabrication material, ceramic
EXTERNAL STAIN KIT 73g
KURARAY NORITAKE DENTAL INC.
103-0050KA
In Commercial Distribution

  • EKUR1030050KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Glaze 30g
KURARAY NORITAKE DENTAL INC.
102-3674KA
In Commercial Distribution

  • EKUR1023674KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Glaze 10g
KURARAY NORITAKE DENTAL INC.
102-3661KA
In Commercial Distribution

  • EKUR1023661KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain D+ 3g
KURARAY NORITAKE DENTAL INC.
102-3651KA
In Commercial Distribution

  • EKUR1023651KA0 ()


  • Dental appliance fabrication material, ceramic
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