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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AnyOne Internal Implant System
Megagen Implant Co. Ltd
FAS
In Commercial Distribution

  • 08806388299935 ()
FAS

  • Dental implant suprastructure, permanent, preformed
AnyRidge Internal Implant System
Megagen Implant Co. Ltd
FANIHX4010
In Commercial Distribution

  • 08806388297252 ()
M-FANIHX4010C

  • Screw endosteal dental implant, two-piece
AnyRidge Internal Implant System
Megagen Implant Co. Ltd
AANITN6012
In Commercial Distribution

  • 08806388255757 ()
AANITN6012

  • Dental precision attachment simulator/analog, single-use
AnyOne Internal Implant System
Megagen Implant Co. Ltd
KAOPK2000
In Commercial Distribution

  • 08806388250806 ()
KAOPK2000

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
INTERNAL HANGING TRAY 254X242X30MM
BAHADIR USA LLC
Y480.26
In Commercial Distribution

  • B060Y480260 ()


  • Instrument tray, reusable
INTERNAL HANGING TRAY 254X172X30MM
BAHADIR USA LLC
Y480.24
In Commercial Distribution

  • B060Y480240 ()


  • Instrument tray, reusable
INTERNAL HANGING TRAY 254X122X30MM
BAHADIR USA LLC
Y480.22
In Commercial Distribution

  • B060Y480220 ()


  • Instrument tray, reusable
INTERNAL HANGING TRAY 254X72X30MM
BAHADIR USA LLC
Y480.20
In Commercial Distribution

  • B060Y480200 ()


  • Instrument tray, reusable
INTERNAL COUNTERTORQUE WITH T-HANDLE
Synthes GmbH
388.143
In Commercial Distribution

  • 07611819128774 ()
  • H9813881430 ()
  • 10705034772035 ()
388143

  • Surgical torque wrench, reusable
F60 SL ENG Internal
FLIGHT MEDICAL INNOVATIONS LTD
V100-0003-PK
In Commercial Distribution

  • 17290013641387 ()


  • Transport electric ventilator
  • Anaesthesia ventilator
F60 DL ENG Internal
FLIGHT MEDICAL INNOVATIONS LTD
V100-0004-PK
In Commercial Distribution

  • 17290013641363 ()


  • Anaesthesia ventilator
  • Transport electric ventilator
F60 DL Sym Internal
FLIGHT MEDICAL INNOVATIONS LTD
V100-0002-PK
In Commercial Distribution

  • 17290013641264 ()


  • Transport electric ventilator
  • Anaesthesia ventilator
Occluder, Internal Vessel, Temporary
GENZYME CORPORATION
LG250
Not in Commercial Distribution

  • 20358468019046 ()

  • one 2.5 mL syringe with 1 cannula (3.0 x 80 mm)
  • Total Volume: 2.5 Milliliter


  • Intravascular occluding solution kit
Occluder, Internal Vessel, Temporary
GENZYME CORPORATION
LG100
Not in Commercial Distribution

  • 20358468019039 ()

  • Total Volume: 1 Milliliter
  • one 1.0 mL syringe with three cannulae (1.0 x 40 mm, 1.5 x 40 mm and 3.0 x 80 mm)


  • Intravascular occluding solution kit
Small Switched Internal Paddles
Philips Medical Systems Hsg
989803109761
In Commercial Distribution

  • 00884838003354 ()
M4744A

  • Internal defibrillation electrode, adult, reusable
Large Switched Internal Paddles
Philips Medical Systems Hsg
989803109741
In Commercial Distribution

  • 00884838003330 ()
M4742A

  • Internal defibrillation electrode, adult, reusable
Medium Switched Internal Paddles
Philips Medical Systems Hsg
989803109751
In Commercial Distribution

  • 00884838003347 ()
M4743A

  • Internal defibrillation electrode, adult, reusable
Internal Sinus Lift System
Hager & Meisinger Gesellschaft mit beschränkter Haftung
CSL00
In Commercial Distribution

  • E0HM79CSL001 ()
CSL00

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Internal Sinus Lift System
Hager & Meisinger Gesellschaft mit beschränkter Haftung
BSL00
In Commercial Distribution

  • E0HM79BSL001 ()
BSL00

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
INTERNAL MIDFACE DISTRACTOR, 20MM
Stryker Leibinger GmbH & Co. KG
62-00420
In Commercial Distribution

  • 07613252133759 ()

  • Length: 53.0 Millimeter
  • Length: 20.0 Millimeter
62-00420

  • Implantable craniofacial bone distractor
INTERNAL MIDFACE DISTRACTOR, 35MM
Stryker Leibinger GmbH & Co. KG
62-00435
In Commercial Distribution

  • 07613252133742 ()

  • Length: 68.0 Millimeter
  • Length: 35.0 Millimeter
62-00435

  • Implantable craniofacial bone distractor
Tap Internal Hex 5.7
BLUE SKY BIO LLC
TAPH57
In Commercial Distribution

  • 00810060224601 ()


  • Fixture/appliance dental drill bit, reusable
Tap Internal Hex 4.7
BLUE SKY BIO LLC
TAPH47
In Commercial Distribution

  • 00810060224595 ()


  • Fixture/appliance dental drill bit, reusable
Tap Internal Hex 4.1
BLUE SKY BIO LLC
TAPH41
In Commercial Distribution

  • 00810060224588 ()


  • Fixture/appliance dental drill bit, reusable
Tap Internal Hex 3.7
BLUE SKY BIO LLC
TAPH37
In Commercial Distribution

  • 00810060224571 ()


  • Fixture/appliance dental drill bit, reusable
Prosthetic screw internal hexagon
Nobel Biocare AB
32983
In Commercial Distribution

  • 07332747022247 ()
32983

  • Dental prosthesis/implant abutment screw
Implant Analog Internal Hex.
DITRON DENTAL LTD
AN-2010
In Commercial Distribution

  • 07290109282299 ()
AN-2010

  • Dental implant analog
RELINE-O Handle, Reducer Internal
Nuvasive, Inc.
10000911
In Commercial Distribution

  • 00887517651709 ()


  • Surgical instrument handle, non-torque-limiting
Implant analog internal hex.
MIS Implants Technologies Ltd.
MD-RSM10
In Commercial Distribution

  • 07290109003368 ()
MD-RSM10

  • Dental implant suprastructure, temporary, preformed, single-use
Internal Stain Bright 3g
KURARAY NORITAKE DENTAL INC.
108-1991KA
In Commercial Distribution

  • EKUR1081991KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain Fluoro 3g
KURARAY NORITAKE DENTAL INC.
108-1981KA
In Commercial Distribution

  • EKUR1081981KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain D+ 3g
KURARAY NORITAKE DENTAL INC.
108-1971KA
In Commercial Distribution

  • EKUR1081971KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain C+ 3g
KURARAY NORITAKE DENTAL INC.
108-1961KA
In Commercial Distribution

  • EKUR1081961KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
108-1951KA
In Commercial Distribution

  • EKUR1081951KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain A+ 3g
KURARAY NORITAKE DENTAL INC.
108-1941KA
In Commercial Distribution

  • EKUR1081941KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain Red 3g
KURARAY NORITAKE DENTAL INC.
108-1921KA
In Commercial Distribution

  • EKUR1081921KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain Gray 3g
KURARAY NORITAKE DENTAL INC.
108-1821KA
In Commercial Distribution

  • EKUR1081821KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain White 3g
KURARAY NORITAKE DENTAL INC.
108-1811KA
In Commercial Distribution

  • EKUR1081811KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain Bright 3g
KURARAY NORITAKE DENTAL INC.
107-1841KA
In Commercial Distribution

  • EKUR1071841KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain Fluoro 3g
KURARAY NORITAKE DENTAL INC.
107-1831KA
In Commercial Distribution

  • EKUR1071831KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain D+ 3g
KURARAY NORITAKE DENTAL INC.
107-1821KA
In Commercial Distribution

  • EKUR1071821KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain C+ 3g
KURARAY NORITAKE DENTAL INC.
107-1811KA
In Commercial Distribution

  • EKUR1071811KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain B+ 3g
KURARAY NORITAKE DENTAL INC.
107-1801KA
In Commercial Distribution

  • EKUR1071801KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain A+ 3g
KURARAY NORITAKE DENTAL INC.
107-1791KA
In Commercial Distribution

  • EKUR1071791KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain Red 3g
KURARAY NORITAKE DENTAL INC.
107-1771KA
In Commercial Distribution

  • EKUR1071771KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain Gray 3g
KURARAY NORITAKE DENTAL INC.
107-1671KA
In Commercial Distribution

  • EKUR1071671KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain White 3g
KURARAY NORITAKE DENTAL INC.
107-1661KA
In Commercial Distribution

  • EKUR1071661KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Hex Analog, Ø4.5mm
INTRA-LOCK INTERNATIONAL, INC.
IHAW
In Commercial Distribution

  • D742IHAW0 ()
IHAW

  • Dental implant system
Internal Stain Bright 3g
KURARAY NORITAKE DENTAL INC.
104-3871KA
In Commercial Distribution

  • EKUR1043871KA0 ()


  • Dental appliance fabrication material, ceramic
Internal Stain Fluoro 3g
KURARAY NORITAKE DENTAL INC.
104-3861KA
In Commercial Distribution

  • EKUR1043861KA0 ()


  • Dental appliance fabrication material, ceramic
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