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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2.0mm Driver Stem w/Post, Long, Hex
OSTEOMED LLC
114-2034
In Commercial Distribution

  • 00842528100158 ()

  • Outer Diameter: 2 Millimeter
114-2034

  • General internal orthopaedic fixation system implantation kit
2.0mm Driver Stem w/Post, Medium, Hex
OSTEOMED LLC
114-2022
In Commercial Distribution

  • 00842528100141 ()

  • Outer Diameter: 2 Millimeter
114-2022

  • General internal orthopaedic fixation system implantation kit
2.0mm Driver Stem w/Post, Short, Hex
OSTEOMED LLC
114-2016
In Commercial Distribution

  • 00842528100134 ()

  • Outer Diameter: 2 Millimeter
114-2016

  • General internal orthopaedic fixation system implantation kit
1.6mm Driver Stem w/Post, Long, Hex
OSTEOMED LLC
114-1634
In Commercial Distribution

  • 00842528100127 ()

  • Outer Diameter: 1.6 Millimeter
114-1634

  • General internal orthopaedic fixation system implantation kit
1.6mm Driver Stem w/Post, Medium, Hex
OSTEOMED LLC
114-1622
In Commercial Distribution

  • 00842528100110 ()

  • Outer Diameter: 1.6 Millimeter
114-1622

  • General internal orthopaedic fixation system implantation kit
1.6mm Driver Stem w/Post, Short, Hex
OSTEOMED LLC
114-1616
In Commercial Distribution

  • 00842528100103 ()

  • Outer Diameter: 1.6 Millimeter
114-1616

  • General internal orthopaedic fixation system implantation kit
No Description
Paradigm Spine GmbH
HAT80112
In Commercial Distribution

  • 04260148896712 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
HAT80102
In Commercial Distribution

  • 04260148896705 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
HAT80300
In Commercial Distribution

  • 04260148896347 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
HAT80110
In Commercial Distribution

  • 04260148896309 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
HAT80100
In Commercial Distribution

  • 04260148896293 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
DAT00155
In Commercial Distribution

  • 04260148893520 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
DAT70505
In Commercial Distribution

  • 04260148893476 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
DAT00150
In Commercial Distribution

  • 04260148892998 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
DAT70500
In Commercial Distribution

  • 04260148891298 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Paradigm Spine GmbH
DAT00100
In Commercial Distribution

  • 04260148890963 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zfx GmbH
ZFX02HLD36
In Commercial Distribution

  • 04251881700466 ()


  • Surgical screwdriver, reusable
No Description
Zfx GmbH
ZFX02HLD21
In Commercial Distribution

  • 04251881700428 ()


  • Surgical screwdriver, reusable
Torque Screw Driver with Holding Sleeve
GPC MEDICAL LIMITED
ILBS787
In Commercial Distribution

  • 08904400233407 ()


  • General external orthopaedic fixation system implantation kit, reusable
William Screw Driver
GPC MEDICAL LIMITED
IBS748
In Commercial Distribution

  • 08904400201215 ()


  • General external orthopaedic fixation system implantation kit, reusable
Screw Driver Metal Handle
GPC MEDICAL LIMITED
IBS743
In Commercial Distribution

  • 08904400201192 ()


  • General external orthopaedic fixation system implantation kit, reusable
Screw Driver Shaft Q.C
GPC MEDICAL LIMITED
ILBS746
In Commercial Distribution

  • 08904400201178 ()


  • General external orthopaedic fixation system implantation kit, reusable
Screw Driver with Holding Sleeve
GPC MEDICAL LIMITED
IBS786
In Commercial Distribution

  • 08904400201154 ()


  • General external orthopaedic fixation system implantation kit, reusable
45° Geared T15 Driver Tip, Short
Altus Spine, LLC
1030-0301G-45
In Commercial Distribution

  • 00843210189437 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-4240
In Commercial Distribution

  • 00843210189420 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-4235
In Commercial Distribution

  • 00843210189413 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-4230
In Commercial Distribution

  • 00843210189406 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-4225
In Commercial Distribution

  • 00843210189390 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-4220
In Commercial Distribution

  • 00843210189383 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-4215
In Commercial Distribution

  • 00843210189376 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0240
In Commercial Distribution

  • 00843210189369 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0235
In Commercial Distribution

  • 00843210189352 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0230
In Commercial Distribution

  • 00843210189345 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0225
In Commercial Distribution

  • 00843210189338 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0220
In Commercial Distribution

  • 00843210189321 ()


  • Surgical screwdriver, reusable
4.2mm Dia. Drill, 15mm
Altus Spine, LLC
1030-0215
In Commercial Distribution

  • 00843210189314 ()


  • Surgical screwdriver, 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-313
In Commercial Distribution

  • 18859751213134 ()
  • 08859751213137 ()


  • 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
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-311
In Commercial Distribution

  • 18859751213110 ()
  • 08859751213113 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MICROCECT CURETTE, BACKWARD ANGLE, #2
HNM STAINLESS, LLC.
HNM-2-13-1002
In Commercial Distribution

  • 00842962162712 ()
HNM-2-13-1002

  • Surgical mallet
MICROCECT CURETTE, BACKWARD ANGLE, #1
HNM STAINLESS, LLC.
HNM-2-13-1001
In Commercial Distribution

  • 00842962162705 ()
HNM-2-13-1001

  • Surgical mallet
KOCHER HEMOSTATIC FORCEPS, 5 5/8", STR
HNM STAINLESS, LLC.
HNM-1-16-1214
In Commercial Distribution

  • 00842962162699 ()
HNM-1-16-1214

  • Surgical mallet
SUTURE RETRIEVER STRAIGHT, SERRATED WL 6" 155MM
HNM STAINLESS, LLC.
HNM-5-820-300
In Commercial Distribution

  • 00842962162682 ()
HNM-5-820-300

  • Surgical mallet
HIGH-SIDED PERFORATED TRAY, 8X5X2"
HNM STAINLESS, LLC.
HNM-36-151841
In Commercial Distribution

  • 00842962162675 ()
HNM-36-151841

  • Surgical mallet
8" KERRISON RONGEUR 4MM
HNM STAINLESS, LLC.
HNM-09-150274
In Commercial Distribution

  • 00842962162668 ()
HNM-09-150274

  • Surgical mallet
8" KERRISON RONGEUR 4MM
HNM STAINLESS, LLC.
HNM-10-5844
In Commercial Distribution

  • 00842962162651 ()
HNM-10-5844

  • Surgical mallet
DOANE "Z" KNEE RETRACTOR - LARGE
HNM STAINLESS, LLC.
HNM-1-78-5998
In Commercial Distribution

  • 00842962162644 ()
HNM-1-78-5998

  • Surgical mallet
MICHEL SUTURE CLIP, 20mm, 1000/PK
HNM STAINLESS, LLC.
HNM-1-13-8020
In Commercial Distribution

  • 00842962162637 ()
HNM-1-13-8020

  • Surgical mallet
DENNISTON DILATOR, SOFT PLASTIC, DOUBLE ENDED, SET OF 5
HNM STAINLESS, LLC.
HNM-36-150523
Not in Commercial Distribution

  • 00842962162620 ()
HNM-36-150523

  • Surgical mallet
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