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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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Leixir Premium Starter Kit, Unigrip - D990LXDGPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
LXDG-PSK
In Commercial Distribution

  • D990LXDGPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Torque Driver 1PK - D990LTD0

No Description
SMART DENTURE CONVERSIONS, LLC
LTD
In Commercial Distribution

  • D990LTD0 ()


  • Surgical screwdriver, reusable

Starter Kit, TiLobe (Quad Drive) - D990KDTLSK0

No Description
SMART DENTURE CONVERSIONS, LLC
KDTL-SK
In Commercial Distribution

  • D990KDTLSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Premium Starter Kit, TiLobe (Quad Drive) - D990KDTLPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
KDTL-PSK
In Commercial Distribution

  • D990KDTLPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Torque Driver 1PK, TiLobe (Quad Drive) - D990KDTLLTD0

No Description
SMART DENTURE CONVERSIONS, LLC
KDTL-LTD
In Commercial Distribution

  • D990KDTLLTD0 ()


  • Surgical screwdriver, reusable

Starter Kit, Paltop (IHex) - D990KDIHSK0

No Description
SMART DENTURE CONVERSIONS, LLC
KDIH-SK
In Commercial Distribution

  • D990KDIHSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Premium Starter Kit, Paltop (IHex) - D990KDIHPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
KDIH-PSK
In Commercial Distribution

  • D990KDIHPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Torque Driver 1PK, Paltop (IHex) - D990KDIHLTD0

No Description
SMART DENTURE CONVERSIONS, LLC
KDIH-LTD
In Commercial Distribution

  • D990KDIHLTD0 ()


  • Surgical screwdriver, reusable

Tall Separable Fastener 10-Pack, w/ Cementation Aid, Ditron - D990DDUSTSFCA10PK0

No Description
SMART DENTURE CONVERSIONS, LLC
DDUS-TSFCA10PK
In Commercial Distribution

  • D990DDUSTSFCA10PK0 ()


  • Surgical screwdriver, reusable
  • Dental prosthesis/implant abutment screw analog, single-use

Cementation Aid 10PK - D990CA10PK0

No Description
SMART DENTURE CONVERSIONS, LLC
CA10PK
In Commercial Distribution

  • D990CA10PK0 ()


  • Surgical screwdriver, reusable

Starter Kit, BioHorizons - D990BHHDSK0

No Description
SMART DENTURE CONVERSIONS, LLC
BHHD-SK
In Commercial Distribution

  • D990BHHDSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Premium Starter Kit, BioHorizons - D990BHHDPSK0

No Description
SMART DENTURE CONVERSIONS, LLC
BHHD-PSK
In Commercial Distribution

  • D990BHHDPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use

Medtronic Resuable Instruments - 00643169713666

DRIVER EX1115089 TAPERED T27 243MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1115089
In Commercial Distribution

  • 00643169713666 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169662667

DRIVER X0715045 NUT 20MM 3-LUG
MEDTRONIC SOFAMOR DANEK, INC.
X0715045
In Commercial Distribution

  • 00643169662667 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169652224

DRIVER EX0615015 BONESCREW T-25
MEDTRONIC SOFAMOR DANEK, INC.
EX0615015
In Commercial Distribution

  • 00643169652224 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169694125

SCREWDRIVER EX0915017 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0915017
In Commercial Distribution

  • 00643169694125 ()


  • Surgical screwdriver, reusable

NA - 00643169693838

DRIVER NAV2024K SOLERA 4.75 STANDARD MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2024K
In Commercial Distribution

  • 00643169693838 ()

  • Outer Diameter: 4.75 Millimeter


  • Surgical screwdriver, reusable

CD HORIZON® Spinal System - 00643169693821

DRIVER NAV2024 SOLERA 4.75 STANDARD MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2024
In Commercial Distribution

  • 00643169693821 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169693715

PENFIELD X1015037 6.5 PUSH/PULL
MEDTRONIC SOFAMOR DANEK, INC.
X1015037
In Commercial Distribution

  • 00643169693715 ()


  • Surgical screwdriver, reusable

CD HORIZON® Fenestrated Screw Set - 00643169679429

DRIVER 7480755T 5.5/6.0 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
7480755T
In Commercial Distribution

  • 00643169679429 ()


  • Orthopaedic implant driver

CD HORIZON® Fenestrated Screw Set - 00643169679412

DRIVER 7480745T 4.75 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
7480745T
In Commercial Distribution

  • 00643169679412 ()


  • Orthopaedic implant driver

CD HORIZON® Fenestrated Screw Set - 00643169679405

SHAFT 7480741T ADAPTER DRIVER QC SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
7480741T
In Commercial Distribution

  • 00643169679405 ()


  • Orthopaedic implant driver

N/A - 00643169641617

DRIVER 5482304 7/32 BREAKOFF DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5482304
In Commercial Distribution

  • 00643169641617 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169693678

ADAPTER X1015013 INLINE
MEDTRONIC SOFAMOR DANEK, INC.
X1015013
In Commercial Distribution

  • 00643169693678 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169693661

DRIVER X1015012 INLINE
MEDTRONIC SOFAMOR DANEK, INC.
X1015012
In Commercial Distribution

  • 00643169693661 ()


  • Orthopaedic implant driver

N/A - 00643169674592

ADAPTER X0815099 OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
X0815099
In Commercial Distribution

  • 00643169674592 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169674561

DRIVER X0815096 OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
X0815096
In Commercial Distribution

  • 00643169674561 ()


  • Orthopaedic implant driver

N/A - 00643169672857

DRIVER NAV2081K VERT THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV2081K
In Commercial Distribution

  • 00643169672857 ()


  • Surgical screwdriver, reusable

neoClose 2 Anchor (Long Driver) US - 05391529640552

Laparoscopy wound closure system pack consists of: 05391529640439; neoClose Anchor (Long Driver) x 2 US; Model Number NCAALX2-U
NEOSURGICAL LIMITED
NCAALX2-U
In Commercial Distribution

  • 05391529640569 ()
  • 05391529640552 ()
  • 05391529640439 ()


  • Laparoscopic wound closure thread

Apex - 05391529588700

Flexible IM Reamer Shaft 650mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1156
In Commercial Distribution

  • 05391529588700 ()

  • 3.2 x 227.0mm
INS-1156

  • Medullary canal orthopaedic reamer shaft

Apex - 05391529583057

Flexible IM reamer Shaft 470mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1095
In Commercial Distribution

  • 05391529583057 ()

  • 470.0 mm
INS-1095

  • Medullary canal orthopaedic reamer shaft

Apex - 05391529582883

Long Screw Hex Driver (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1078
In Commercial Distribution

  • 05391529582883 ()
INS-1078

  • Surgical screwdriver, reusable

Apex - 05391529582876

Short Screw Hex Driver (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1077
In Commercial Distribution

  • 05391529582876 ()
INS-1077

  • Surgical screwdriver, reusable

Apex - 05391529582869

Short Screw Driver With Retention Hex (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1076
In Commercial Distribution

  • 05391529582869 ()
INS-1076

  • Surgical screwdriver, reusable

Apex - 05391529582852

Hex Driver (5mm/8mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1075
In Commercial Distribution

  • 05391529582852 ()
INS-1075

  • Surgical screwdriver, reusable

Apex - 05391529582760

Mallet
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1065
In Commercial Distribution

  • 05391529582760 ()
INS-1065

  • Surgical mallet

Apex - 05391529582739

Long Screw Driver With Retention Hex (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1060
In Commercial Distribution

  • 05391529582739 ()
INS-1060

  • Surgical screwdriver, reusable

Apex - 05391529582722

Driver With Retention Hex (5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1059
In Commercial Distribution

  • 05391529582722 ()
INS-1059

  • Surgical screwdriver, reusable

Apex - 05391529581640

Flexible IM Reamer Shaft Extension 150mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1135
In Commercial Distribution

  • 05391529581640 ()

  • 150 mm
INS-1135

  • Medullary canal orthopaedic reamer shaft

Apex - 05391529588656

Flexible Hex Driver Ball Tip (5mm/8mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1151
In Commercial Distribution

  • 05391529588656 ()

  • Ø7.92 x 195mm
INS-1151

  • Surgical screwdriver, reusable

Apex - 05391529581855

Long Removal and Insertion Hex (5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1136
In Commercial Distribution

  • 05391529581855 ()
INS-1136

  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169713949

SCREWDRIVER X1215024 LNG MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1215024
In Commercial Distribution

  • 00643169713949 ()


  • Surgical screwdriver, reusable

Instrument - 05060296233631

Hammer
Stanmore Implants Worldwide Ltd
imham
Not in Commercial Distribution

  • 05060296233631 ()
IMHAM

  • Surgical mallet

Infinity-Lock Button System - 05060267131836

No Description
XIROS LTD
102-1089
In Commercial Distribution

  • 05060267131836 ()
n/a

  • Acromioclavicular joint stabilization implant
  • Cannulated surgical drill bit, single-use

Impactor Assembly - 05060267130785

No Description
XIROS LTD
202-1137
In Commercial Distribution

  • 05060267130785 ()
n/a

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981310110

Split Tip Mariner Tulip Cap Driver
Seaspine Orthopedics Corporation
SR-1081
In Commercial Distribution

  • 10889981310110 ()
SR-1081

  • Orthopaedic implant driver

Specials - 10889981308520

Hex Driver, T30, Tri-Flat Connect
Seaspine Orthopedics Corporation
SR-1046
In Commercial Distribution

  • 10889981308520 ()
SR-1046

  • Orthopaedic implant driver

NorthStar - 10889981307158

OCC Fixed Angle DTS Driver
Seaspine Orthopedics Corporation
PC2-300030
In Commercial Distribution

  • 10889981307158 ()
PC2-300030

  • Orthopaedic implant driver

NorthStar - 10889981307141

OCC Straight DTS Driver
Seaspine Orthopedics Corporation
PC2-300000
In Commercial Distribution

  • 10889981307141 ()
PC2-300000

  • Orthopaedic implant driver

Specials - 10889981306717

NorthStar Navigation Driver, 1/4" Connect
Seaspine Orthopedics Corporation
SR-0955
In Commercial Distribution

  • 10889981306717 ()
SR-0955

  • Orthopaedic implant driver
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