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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COLLIN LUCAE BONE MALLET, 8", SOLID, 1 1/4" HEAD, 7 1/2 OZ
HNM STAINLESS, LLC.
HNM-1-27-0422
In Commercial Distribution

  • 00842962115930 ()
HNM-1-27-0422

  • Surgical mallet
MALLET, 6 1/2", SMALL, 8 OZ
HNM STAINLESS, LLC.
HNM-1-27-0213
In Commercial Distribution

  • 00842962115916 ()
HNM-1-27-0213

  • Surgical mallet
ParaPost Fiber White One Office Visit Technique Introductory Kit Contents: 10 Fiber Posts, (3) #4.5, (3) #5, (2) #5.5, (2) #6 4 Drills, (1) #4.5, (1) #5, (1) #5.5, (1) #6 1 Universal Hand Driver
COLTENE/WHALEDENT INC
PF160
In Commercial Distribution

  • D661PF1600 ()
  • 00840016201585 ()
  • D661PF1601 ()


  • Root canal post, preformed
UNIVERSAL HAND DRIVER
COLTENE/WHALEDENT INC
L590C
In Commercial Distribution

  • D661L590C1 ()


  • Pin/post dental drill bit
Universal Hand Driver
COLTENE/WHALEDENT INC
L590
In Commercial Distribution

  • D661L5900 ()


  • Pin/post dental drill bit
Height Adjustable Driver
L&K BIOMED CO. ,LTD.
CM0064-PT01-0002
In Commercial Distribution

  • 08809986468345 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Screw Driver
L&K BIOMED CO. ,LTD.
CM0061-CP02-0601
In Commercial Distribution

  • 08809986468314 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
MIS Cannulated Screw Driver
L&K BIOMED CO. ,LTD.
LS05-2402
In Commercial Distribution

  • 08809986466488 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Height Adjustable Driver
L&K BIOMED CO. ,LTD.
BT01-0002
In Commercial Distribution

  • 08809986466440 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-314
In Commercial Distribution

  • 18859751213141 ()
  • 08859751213144 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-312
In Commercial Distribution

  • 18859751213127 ()
  • 08859751213120 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Single-Use Surgical Tool
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52260
Not in Commercial Distribution

  • 09008737522605 ()


  • Surgical screwdriver, single-use
Single-Use Surgical Tool
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52790
In Commercial Distribution

  • 09008737527907 ()


  • Surgical screwdriver, single-use
T-25 Drive Shaft, Long
Altus Spine, LLC
908-0052
In Commercial Distribution

  • 00843210134611 ()


  • Surgical screwdriver, reusable
T-25 Removable Tip, Tapered
Altus Spine, LLC
905-1955
In Commercial Distribution

  • 00843210134567 ()


  • Surgical screwdriver, reusable
T-25 Final Drive Shaft
Altus Spine, LLC
905-1011
In Commercial Distribution

  • 00843210134550 ()


  • Surgical screwdriver, reusable
PSS: Screwdriver
Altus Spine, LLC
900-1024
In Commercial Distribution

  • 00843210134369 ()


  • Surgical screwdriver, reusable
PSS: Disposable Tip
Altus Spine, LLC
900-1019
Not in Commercial Distribution

  • 00843210134314 ()


  • Surgical screwdriver, single-use
PSS: Cross Connector Cam Drive
Altus Spine, LLC
900-1016
In Commercial Distribution

  • 00843210134307 ()


  • Surgical screwdriver, reusable
Large Slap Hammer
Altus Spine, LLC
780-0023
In Commercial Distribution

  • 00843210134147 ()


  • Surgical mallet
Large Slap Hammer
Altus Spine, LLC
780-0022
In Commercial Distribution

  • 00843210134130 ()


  • Surgical mallet
Slap Hammer Adaptor 5/16
Altus Spine, LLC
780-0012
In Commercial Distribution

  • 00843210134109 ()


  • Surgical mallet
Slap Hammer
Altus Spine, LLC
780-0002
In Commercial Distribution

  • 00843210134048 ()


  • Surgical mallet
T25 Retractor Driver
Altus Spine, LLC
600-0014
In Commercial Distribution

  • 00843210133386 ()


  • Surgical screwdriver, reusable
Self Retaining Driver
Altus Spine, LLC
100-3100
In Commercial Distribution

  • 00843210133300 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SSP: SCP Screwdriver
Altus Spine, LLC
100-1010
In Commercial Distribution

  • 00843210133201 ()


  • Surgical screwdriver, reusable
SSP: Utility Driver
Altus Spine, LLC
100-1002
In Commercial Distribution

  • 00843210133188 ()


  • Surgical screwdriver, reusable
Polyaxial Screwdriver
Altus Spine, LLC
880-1027
In Commercial Distribution

  • 00843210132785 ()


  • Surgical screwdriver, reusable
TA25 Locking Driver Closed Head Screw, Small Hudson
Altus Spine, LLC
990-4133TS
In Commercial Distribution

  • 00843210132693 ()


  • Surgical screwdriver, reusable
T25 Locking Driver Closed Head Screw
Altus Spine, LLC
990-4133
In Commercial Distribution

  • 00843210132686 ()


  • Surgical screwdriver, reusable
MIS TA25 Extension Locking Driver
Altus Spine, LLC
981-0005TN
In Commercial Distribution

  • 00843210132679 ()


  • Surgical screwdriver, reusable
MIS TA25 Extension Locking Driver, Square
Altus Spine, LLC
981-0004TS
In Commercial Distribution

  • 00843210132662 ()


  • Surgical screwdriver, reusable
MIS TA25 Extension Locking Driver
Altus Spine, LLC
981-0004TN
In Commercial Distribution

  • 00843210132655 ()


  • Surgical screwdriver, reusable
MIS TA25 Extension Locking Driver
Altus Spine, LLC
981-0004T
In Commercial Distribution

  • 00843210132648 ()


  • Surgical screwdriver, reusable
MIS T25 Extension Locking Driver
Altus Spine, LLC
981-0004
In Commercial Distribution

  • 00843210132631 ()


  • Surgical screwdriver, reusable
Locking Driver, Mono-Axial
Altus Spine, LLC
975-0007
In Commercial Distribution

  • 00843210132624 ()


  • Surgical screwdriver, reusable
Locking Driver, Mono-Axial
Altus Spine, LLC
975-0006
In Commercial Distribution

  • 00843210132617 ()


  • Surgical screwdriver, reusable
Locking Driver, Mono-Axial
Altus Spine, LLC
975-0005
In Commercial Distribution

  • 00843210132600 ()


  • Surgical screwdriver, reusable
Locking Driver, Mono-Axial
Altus Spine, LLC
975-0004
In Commercial Distribution

  • 00843210132594 ()


  • Surgical screwdriver, reusable
Locking Driver, Flex Tab, Small Hudson
Altus Spine, LLC
909-4133TS
In Commercial Distribution

  • 00843210132587 ()


  • Surgical screwdriver, reusable
Locking Driver, Flex Tab
Altus Spine, LLC
909-4133
In Commercial Distribution

  • 00843210132570 ()


  • Surgical screwdriver, reusable
TA25 Reduction Locking Driver, Small Hudson
Altus Spine, LLC
909-0003TS
In Commercial Distribution

  • 00843210132563 ()


  • Surgical screwdriver, reusable
T25 Reduction Locking Driver
Altus Spine, LLC
909-0003
In Commercial Distribution

  • 00843210132556 ()


  • Surgical screwdriver, reusable
TA25 Locking Driver, Square
Altus Spine, LLC
908-5133T
In Commercial Distribution

  • 00843210132549 ()


  • Surgical screwdriver, reusable
T25 Locking Driver, Square
Altus Spine, LLC
908-5133
In Commercial Distribution

  • 00843210132532 ()


  • Surgical screwdriver, reusable
T15 Locking Driver, Square
Altus Spine, LLC
908-4415
In Commercial Distribution

  • 00843210132525 ()


  • Surgical screwdriver, reusable
TA25 Locking Driver, Square
Altus Spine, LLC
908-4134TS
In Commercial Distribution

  • 00843210132518 ()


  • Surgical screwdriver, reusable
T25 Locking Driver, Square
Altus Spine, LLC
908-4134
In Commercial Distribution

  • 00843210132501 ()


  • Surgical screwdriver, reusable
TA25 Locking Driver
Altus Spine, LLC
908-4133TN
In Commercial Distribution

  • 00843210132495 ()


  • Surgical screwdriver, reusable
T25 Locking Driver
Altus Spine, LLC
908-4133
In Commercial Distribution

  • 00843210132488 ()


  • Surgical screwdriver, reusable
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