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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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Closed Lateral Connector, 3.5 Rod. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-0035
In Commercial Distribution

  • 10889981042318 ()

  • 3.5
50-0035

  • Cannulated surgical drill bit, single-use
Le Fort Surgical Guide - Wall with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543494 ()
GCLPFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543487 ()
GCLRFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Wall Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543470 ()
GCLPBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543463 ()
GCLRBC

  • Custom-made orthopaedic/craniofacial surgical guide
Final Orthognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543456 ()
FFCOBC

  • Custom-made orthopaedic/craniofacial surgical guide
Intermediate Orhognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543449 ()
FICOBC

  • Custom-made orthopaedic/craniofacial surgical guide
2.0 - 3.2 Pin Driver Assembly
Insurgical, Inc.
320-0070-001
In Commercial Distribution

  • 00860007230066 ()
9250022

  • Pin-driving power tool attachment
3.2 - 4.0 Pin Driver Assembly
Insurgical, Inc.
320-0107-001
In Commercial Distribution

  • 00860007230059 ()
9250023

  • Pin-driving power tool attachment
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet
Seneca Devices, Inc.
EAS-42-Z
In Commercial Distribution

  • 00860004936817 ()


  • Bed mattress support platform, hydraulic
  • Intensive-care patient transport system, ventilatory support, neonatal
Doctor Stool Replacement Rubber Tip
Assembly Required Distributors Inc
CHM8908-01
In Commercial Distribution

  • 00860004575627 ()


  • Walking aid tip
No Description
FlexDex Surgical
8ND1L
In Commercial Distribution

  • 00860004002147 ()


  • Suturing needle holder, reusable
No Description
FlexDex Surgical
8ND1M
In Commercial Distribution

  • 00860004002130 ()


  • Suturing needle holder, reusable
No Description
FlexDex Surgical
FD-335 ND
Not in Commercial Distribution

  • 00860004002116 ()
  • 00860004002109 ()


  • Suturing needle holder, single-use
Pump Driver Service Replacement Kit
Breethe, Inc.
001-0301-003
In Commercial Distribution

  • 00860001797947 ()
001-0301-003

  • Cardiopulmonary bypass system, non-roller type
No Description
Jeil Medical Corporation
111-440
In Commercial Distribution

  • 08800089452712 ()


  • Surgical mallet
EXTENDED PROV. PLUG DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X84687E
Not in Commercial Distribution

  • 00721902170126 ()


  • Orthopaedic implant driver
INSTRUMENT 8682050 M8 REDUCTN MAS SCRWDR
MEDTRONIC SOFAMOR DANEK, INC.
8682050
In Commercial Distribution

  • 00721902167850 ()


  • Surgical screwdriver, reusable
CAP 9115877 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
9115877
In Commercial Distribution

  • 00721902163692 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER 9110365 IMPLANT TPRD SLV 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9110365
In Commercial Distribution

  • 00721902096167 ()


  • Orthopaedic implantation sleeve, reusable
DRIVER 9110260 IMPLANT TPRD 14MM
MEDTRONIC SOFAMOR DANEK, INC.
9110260
In Commercial Distribution

  • 00721902096020 ()


  • Orthopaedic implantation sleeve, reusable
LIBERTY CLSD DRVR W/QCK CONN
MEDTRONIC SOFAMOR DANEK, INC.
X812-910
In Commercial Distribution

  • 00721902067655 ()


  • Orthopaedic implant driver
EXT M8 FIXED DRIVER W/MOD HEAD
MEDTRONIC SOFAMOR DANEK, INC.
X858-959
In Commercial Distribution

  • 00721902059575 ()


  • Orthopaedic implant driver
INSTRUMENT 8910640 SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
8910640
In Commercial Distribution

  • 00721902053269 ()


  • Surgical screwdriver, reusable
M8 FIXED SCREWDRIVER W/POST
MEDTRONIC SOFAMOR DANEK, INC.
X0501005
In Commercial Distribution

  • 00721902043758 ()


  • Orthopaedic implant driver
M8MAS DRIVER WITH DRAIN HOLES
MEDTRONIC SOFAMOR DANEK, INC.
X0501002
In Commercial Distribution

  • 00721902043741 ()


  • Orthopaedic implant driver
EASY CLEAN M8MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0501001
In Commercial Distribution

  • 00721902043734 ()


  • Orthopaedic implant driver
INSTRUMENT 858-959 IG M8 FIXED SCRWDRVER
MEDTRONIC SOFAMOR DANEK, INC.
858-959
In Commercial Distribution

  • 00721902038662 ()


  • Surgical screwdriver, reusable
ACCY KIT 355015 BURR HOLE
MEDTRONIC, INC.
355015
Not in Commercial Distribution

  • 00721902036378 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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