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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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RKS, Ball End Hex Driver, 3mm, SS
Shalby Advanced Technologies, Inc.
2970-0-0026
In Commercial Distribution

  • 00840286842983 ()

  • Ball End Hex Driver, 3mm, SS
2970-0-0026

  • Surgical screwdriver, reusable
Romero Cervical Screw Driver Shaft Ball Joint Quick Connect - 15mm
Spineup, Inc.
RO0036SDBJ
In Commercial Distribution

  • B806RO0036SDBJ0 ()
RO0036SDBJ

  • Orthopaedic implant driver
Romero Cervical Screw Driver Shaft Ball Joint Quick Connect - 25mm
Spineup, Inc.
RO0034SDBJ
In Commercial Distribution

  • B806RO0034SDBJ0 ()
RO0034SDBJ

  • Orthopaedic implant driver
Small Slotted Mallet
Spineup, Inc.
GN0001SSMZ
In Commercial Distribution

  • B806GN0001SSMZ0 ()
GN0001SSMZ

  • Surgical mallet
Driver, Tapered
Pioneer Surgical Technology, Inc.
58-202230100
In Commercial Distribution

  • 00840298700660 ()
2022-30-100

  • Surgical screwdriver, reusable
Fixation Pin, Tri face with Tri Hub, OD 3.2mm, 4" Long
Shalby Advanced Technologies, Inc.
2801-0-3432
In Commercial Distribution

  • 00840286859950 ()

  • Fixation Pin, Tri face with Tri Hub, OD 3.2mm, 4" Long
2801-0-3432

  • Orthopaedic intraoperative positioning pin, reusable
Flexible Drilling Shaft, 60°, Assembly
Shalby Advanced Technologies, Inc.
1801-1-1215
In Commercial Distribution

  • 00840286855631 ()

  • Flexible Drilling Shaft, 60°, Assembly
1801-1-1215

  • Surgical screwdriver, reusable
UJ Screwdriver, Assembly, 3.5 Hex
Shalby Advanced Technologies, Inc.
1801-0-1350
In Commercial Distribution

  • 00840286855624 ()

  • UJ Screwdriver, Assembly, 3.5 Hex
1801-0-1350

  • Surgical screwdriver, reusable
Straight Hex Screwdriver
Shalby Advanced Technologies, Inc.
1801-0-1340
In Commercial Distribution

  • 00840286855617 ()

  • Straight Hex Screwdriver
1801-0-1340

  • Surgical screwdriver, reusable
Fixation Pin, w/Cut-Out, Ø 3.2mm., 4" Long
Shalby Advanced Technologies, Inc.
2800-1-1432
In Commercial Distribution

  • 00840286855167 ()

  • Fixation Pin, w/Cut-Out, Ø 3.2mm., 4" Long
2800-1-1432

  • Orthopaedic intraoperative positioning pin, reusable
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