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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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Mono, D3.3, L16, One Piece Ti. Implant
NORIS MEDICAL LTD
NM-V3316
In Commercial Distribution

  • 07290108814620 ()
NM-V3316

  • Screw endosteal dental implant, one-piece
Mono, D3.3, L11.5, One Piece Ti. Implant
NORIS MEDICAL LTD
NM-V3311
In Commercial Distribution

  • 07290108814606 ()
NM-V3311

  • Screw endosteal dental implant, one-piece
Mono, D3.3, L10, One Piece Ti. Implant
NORIS MEDICAL LTD
NM-V3310
In Commercial Distribution

  • 07290108814590 ()
NM-V3310

  • Screw endosteal dental implant, one-piece
Mono, D3.0, L16, One Piece Ti. Implant
NORIS MEDICAL LTD
NM-V3016
In Commercial Distribution

  • 07290108814583 ()
NM-V3016

  • Screw endosteal dental implant, one-piece
Mono, D3.0, L13, One Piece Ti. Implant
NORIS MEDICAL LTD
NM-V3013
In Commercial Distribution

  • 07290108814576 ()
NM-V3013

  • Screw endosteal dental implant, one-piece
Mono, D3.0, L11.5, One Piece Ti. Implant
NORIS MEDICAL LTD
NM-V3011
In Commercial Distribution

  • 07290108814569 ()
NM-V3011

  • Screw endosteal dental implant, one-piece
Mono, D3.0, L10, One Piece Ti. Implant
NORIS MEDICAL LTD
NM-V3010
In Commercial Distribution

  • 07290108814552 ()
NM-V3010

  • Screw endosteal dental implant, one-piece
UNO one piece implant motor adapter, long
MIS Implants Technologies Ltd.
MT-UML21
Not in Commercial Distribution

  • 07290109015170 ()
MT-UML21

  • Screwing power tool attachment
One Moving Laser Controller w/ TPS Connectivity
Diacor, Inc.
MLC-1PC
Not in Commercial Distribution

  • B237MLC1PC0 ()


  • Laser patient positioning system
ARMADA Nottingham One Step Dilator 6F/12F
ALLWIN MEDICAL DEVICES, INC.
ARMADA Nottingham One Step Dilator 6F/12F
In Commercial Distribution

  • 10812261012619 ()
  • 00812261012612 ()
NOT 6/12

  • Endoscopic-access dilator, single-use
ARMADA Nottingham One Step Dilator 6F/10F
ALLWIN MEDICAL DEVICES, INC.
ARMADA Nottingham One Step Dilator 6F/10F
In Commercial Distribution

  • 10812261012602 ()
  • 00812261012605 ()
NOT 6/10

  • Endoscopic-access dilator, single-use
NASAL, COTTLE, ANGLED, ONE BLADE SERRATED, TC
KLS-Martin L.P.
11-505-16-07
In Commercial Distribution

  • 00888118013354 ()

  • 16 CM


  • Nasal scissors
NASAL, FOMON, ANGLED, ONE BLADE SERRATED, TC
KLS-Martin L.P.
11-503-15-07
In Commercial Distribution

  • 00888118013347 ()

  • 15 CM


  • Nasal scissors
Robot Arm Interface instrument Rosa One 3.1
MEDTECH
174020-02
In Commercial Distribution

  • 00887868540028 ()
ROSAS00126

  • Multi-purpose stereotactic surgery system
Spetzlerā„¢ Lumbar Peritoneal Shunt, One Piece
Integra Lifesciences Corporation
NL8507210
In Commercial Distribution

  • 10381780024408 ()
  • M269NL85072101 ()
NL8507210

  • Cerebrospinal fluid shunt valve
IPS InLine One Dentcisal 20 g BL
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631850
In Commercial Distribution

631850

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 1
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631851
In Commercial Distribution

631851

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 2
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631852
In Commercial Distribution

631852

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 3
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631853
In Commercial Distribution

631853

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 4
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631854
In Commercial Distribution

631854

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 5
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631855
In Commercial Distribution

631855

  • Dental appliance fabrication material, ceramic
IPS InLine One Dentcisal 20 g 6
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
631856
In Commercial Distribution

631856

  • Dental appliance fabrication material, ceramic
One component bonding, self etch, light cure
Harvard Dental International GmbH
7083218
In Commercial Distribution

  • EHAR70832181 ()


  • Dentine bonding agent/set
Light cure total etch one component bonding
Harvard Dental International GmbH
7083607
In Commercial Distribution

  • EHAR70836071 ()


  • Dentine bonding agent/set
one side satin finished 9.5x7x0.5 - 0.6 cm
Spiggle & Theis Medizintechnik GmbH
10-733-09
In Commercial Distribution

  • 04250374712269 ()
10-733-09

  • Surgical cutting/shaping board, reusable
ACCLEAN ONE STEP FLUORIDE VARNISH MINT -200ct
HENRY SCHEIN, INC.
5700526
In Commercial Distribution

  • 10304040040529 ()
  • 00304040040522 ()
  • 20304040040526 ()

  • Total Volume: 0.4 Milliliter
5700526

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH CHERRY -200ct
HENRY SCHEIN, INC.
5700525
In Commercial Distribution

  • 10304040040512 ()
  • 00304040040515 ()
  • 20304040040519 ()

  • Total Volume: 0.4 Milliliter
5700525

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH CARAMEL -200ct
HENRY SCHEIN, INC.
5700524
In Commercial Distribution

  • 10304040040505 ()
  • 00304040040508 ()
  • 20304040040502 ()

  • Total Volume: 0.4 Milliliter
5700524

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH RASPBERRY -50ct
HENRY SCHEIN, INC.
5700532
In Commercial Distribution

  • 10304040040482 ()
  • 00304040040485 ()
  • 20304040040489 ()

  • Total Volume: 0.4 Milliliter
5700532

  • Dental coating, tooth-desensitizing
ACCLEAN ONE STEP FLUORIDE VARNISH MINT -50ct
HENRY SCHEIN, INC.
5700531
In Commercial Distribution

  • 10304040040475 ()
  • 00304040040478 ()
  • 20304040040472 ()

  • Total Volume: 0.4 Milliliter
5700531

  • Dental coating, tooth-desensitizing
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