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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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The Fenestration Punch is used for making small fenestrations in a Provox LaryTube at desired locations.
Atos Medical AB
7654
Not in Commercial Distribution

  • 07331791002632 ()
7654

  • Tracheostomy tube, non-reinforced, non-customized, reusable
RENASYS EDGE Carry Bag
SMITH & NEPHEW MEDICAL LIMITED
66803136
In Commercial Distribution

  • 05000223501136 ()
  • 05000223501129 ()

  • 172x135 x134W x H x Dmm (approximate dimensions with strap at longest)
66803136

  • Negative-pressure wound therapy system, electric, 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
A comprehensive at home fertility test that measures four key hormones that impact your cycle and fertility.
Mfb Fertility, Inc.
Complete
In Commercial Distribution

  • 00850035206065 ()


  • Natural conception assistance kit
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