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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CDS Spring NC – 4.5N
OSTEOMED LLC
218-3145-SP
In Commercial Distribution

  • 00845694053624 ()

  • Force = 4.5 N
218-3145-SP

  • Implantable craniofacial bone distractor
CDS Spring NC – 4N
OSTEOMED LLC
218-3140-SP
In Commercial Distribution

  • 00845694053617 ()

  • Force = 4.0 N
218-3140-SP

  • Implantable craniofacial bone distractor
SmartFlex Cutter
OSTEOMED LLC
220-0773
In Commercial Distribution

  • 00845694045087 ()
220-0773

  • General internal orthopaedic fixation system implantation kit
SmartFlex 5mm Rongeur
OSTEOMED LLC
220-0772
In Commercial Distribution

  • 00845694045070 ()
220-0772

  • General internal orthopaedic fixation system implantation kit
SmartFlex Sterilization Tray
OSTEOMED LLC
220-0770
In Commercial Distribution

  • 00845694045063 ()
220-0770

  • General internal orthopaedic fixation system implantation kit
SmartFlex Inserter
OSTEOMED LLC
220-0771-SP
In Commercial Distribution

  • 00845694045056 ()
220-0771-SP

  • General internal orthopaedic fixation system implantation kit
1.2mm Screw Visidisk Logic Jr (Yellow)
OSTEOMED LLC
216-0502
In Commercial Distribution

  • 00845694044318 ()
216-0502

  • General internal orthopaedic fixation system implantation kit
Cross Cut Rasp, Reciprocating Saw, Mini Shaft, Sterile
OSTEOMED LLC
451-2055-SP
In Commercial Distribution

  • 00842528123706 ()

  • Length: 48.4 Millimeter
451-2055-SP

  • General internal orthopaedic fixation system implantation kit
Left & Right Inferior Border Blade, Reciprocating Saw, Sterile
OSTEOMED LLC
451-8000-SP
In Commercial Distribution

  • 00845694030953 ()
451-8000-SP

  • General internal orthopaedic fixation system implantation kit
0.6mm x 26.3mm Reciprocating Saw Blade, Short Shaft, Sterile
OSTEOMED LLC
451-2326-SP
In Commercial Distribution

  • 00845694030946 ()

  • Length: 26.3 Millimeter
451-2326-SP

  • General internal orthopaedic fixation system implantation kit
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