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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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OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 15 Fasteners
Davol Inc.
0113315
In Commercial Distribution

  • 10801741136556 ()
  • 00801741136559 ()

  • Length: 37 Centimeter
  • Outer Diameter: 5 Millimeter
0113315

  • Soft-tissue/mesh anchor, bioabsorbable
5mm 45cm Endoclinch Fenestrated Grasper, 30deg angled shaft at distal end, designed for Single Site Trocars (Bend Begins at 12cm from Distal Tip), 3-piece modular take-apart, type 6 handle: lightweight carbon-fiber with RF post & ratchet
Avalign Technologies, Inc.
72-5215527C6SST
In Commercial Distribution

  • 00190776297503 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size XXL
STANDARD TEXTILE CO., INC.
75675213
In Commercial Distribution

  • 10634916825388 ()
  • 00634916825381 ()


  • Surgical gown, reusable
Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size X-Large
STANDARD TEXTILE CO., INC.
75675214
In Commercial Distribution

  • 10634916825371 ()
  • 00634916825374 ()


  • Surgical gown, reusable
Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size Large
STANDARD TEXTILE CO., INC.
75675215
In Commercial Distribution

  • 10634916825364 ()
  • 00634916825367 ()


  • Surgical gown, reusable
Portable, battery powered laser therapy device emitting up to 3W at 808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 MaxIR
In Commercial Distribution

  • 00852116008209 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 2W at 635nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 MaxR
In Commercial Distribution

  • 00852116008193 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 3W at 808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProIR
Not in Commercial Distribution

  • 00852116008049 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 2W at 635nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProR
Not in Commercial Distribution

  • 00852116008032 ()


  • Musculoskeletal/physical therapy laser, professional
5mm, 45cm, Suction Tube, Regular Tip Vented, Stainless Steel, Special Hub w/ Specs on File at Elmed
ELMED INCORPORATED
ST52945411JC
In Commercial Distribution

  • 00198506072680 ()
ST52945411JC

  • Laparoscopic surgical procedure kit, non-medicated, reusable
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