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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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HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER KIT WITH DEPTH MARKS, 8F
URESIL, LLC
NCL2-0835HB-K
In Commercial Distribution

  • H862NCL20835HBK2 ()
  • H862NCL20835HBK0 ()

  • Catheter Gauge: 8 French
  • Length: 28 Centimeter
NCL2-0835HB-K

  • Nephrostomy catheter
G-P "HB" Catheter + Fixation Kit - Locking - 10F 30
URESIL, LLC
GPL2-1030HB-KSA
Not in Commercial Distribution

  • H862GPL21030HBKSA2 ()
  • H862GPL21030HBKSA0 ()

  • Catheter Gauge: 10 French
  • Length: 21 Centimeter
GPL2-1030HB-KSA

  • Suction system catheter, general-purpose
G-P "HB" Catheter + Fixation Kit - Locking - 8F 30
URESIL, LLC
GPL2-0830HB-KSA
Not in Commercial Distribution

  • H862GPL20830HBKSA2 ()
  • H862GPL20830HBKSA0 ()

  • Catheter Gauge: 8 French
  • Length: 21 Centimeter
GPL2-0830HB-KSA

  • Suction system catheter, general-purpose
Dale Nasogastric Tube Holder, Large/Adult
Dale Medical Products, Inc.
160
In Commercial Distribution

  • H84101602 ()
  • H84101601 ()
160

  • Nasogastric tube holder, noninvasive
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
Self Sealing Sterilization Pouch/Packaging 2 1/4" x 4"
CERTOL INTERNATIONAL, LLC
PM2440
In Commercial Distribution

  • H816PM24402 ()
  • H816PM24401 ()
  • H816PM24400 ()
PM2440-1

  • Sterilization packaging, single-use
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