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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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Dale Tracheostomy Tube Holder, 1" wide, fits up to 19.5" neck.
Dale Medical Products, Inc.
240
In Commercial Distribution

  • H84102402 ()
  • H84102401 ()
240

  • Tracheostomy tube neck holder, reusable
Dale One Piece tracheostomy tube holder, 1" wide neckband, fits 9.5" to 18" neck.
Dale Medical Products, Inc.
200
Not in Commercial Distribution

  • H84102002 ()
  • H84102001 ()
200

  • Tracheostomy tube neck holder, reusable
Dale Nasogastric Tube Holder, Small / Young Adult / Pediatric / Geriatric
Dale Medical Products, Inc.
161
In Commercial Distribution

  • H84101612 ()
  • H84101611 ()
161

  • Nasogastric tube holder, noninvasive
Dale Nasogastric Tube Holder, Large/Adult
Dale Medical Products, Inc.
160
In Commercial Distribution

  • H84101602 ()
  • H84101601 ()
160

  • Nasogastric tube holder, noninvasive
Dale Foley Catheter Holder, adhesive patch, fits most
Dale Medical Products, Inc.
150
In Commercial Distribution

  • H84101502 ()
  • H84101501 ()
150

  • Urinary catheter holder
Formaldehyde Device Sterilant
CERTOL INTERNATIONAL, LLC
VC338
In Commercial Distribution

  • H816VC3381 ()
  • H816VC3380 ()
VC338-1

  • Formaldehyde device sterilant
Steam Sterilization Integrators
CERTOL INTERNATIONAL, LLC
TSI440
In Commercial Distribution

  • H816TSI4401 ()
  • H816TSI4400 ()
  • H816TSI4402 ()
TSI440-1

  • Chemical/physical sterilization process indicator
Enzymatic Presaturated Endoscopic Cleaning Sponge
MicroCare, LLC
SMQEZ2
In Commercial Distribution

  • H816SMQEZ22 ()
  • H816SMQEZ21 ()
  • H816QEZ21 ()
QEZ2

  • Medical device cleaning agent
Indicator Strips for Steam and Chemical Vapor
CERTOL INTERNATIONAL, LLC
SM4340
In Commercial Distribution

  • H816SM43402 ()
  • H816SM43401 ()
  • H816SM43400 ()
SM4340-1

  • Chemical/physical sterilization process indicator
No Description
CERTOL INTERNATIONAL, LLC
QEZ2
In Commercial Distribution

  • H816QEZ22 ()
  • H816QEZ21 ()
  • H816QEZ20 ()
QEZ2

  • Medical device cleaning agent
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