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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IPS Empress Esthetic Ingot E TC0/10pcs
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574520
Not in Commercial Distribution

  • DIVO5745201 ()
  • DIVO5745200 ()
  • DIVO5745202 ()
574520

  • Dental appliance fabrication material, ceramic
IPS e.max ZirPress LT A3 5 pcs
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
596787
Not in Commercial Distribution

  • DIVO5967871 ()
  • DIVO5967870 ()
  • DIVO5967872 ()
596787

  • Dental appliance fabrication material, ceramic
Percutaneous Drainage Catheter Connector Tubing
URESIL, LLC
PDC-36
In Commercial Distribution

  • H862PDC362 ()
  • H862PDC360 ()

  • Length: 36 Centimeter
PDC-36

  • Closed-wound/centesis drainage receptacle
Biliary "HB" Catheter + Fixation Kit - Locking - 10F 50
URESIL, LLC
CCL2-1050HB-KSA
Not in Commercial Distribution

  • H862CCL21050HBKSA2 ()
  • H862CCL21050HBKSA0 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
CCL2-1050HB-KSA

  • Biliary drain
CHOLE-CATH Biliary Drainage Catheter Kit - 10F
URESIL, LLC
CCL2-1050HB-K
Not in Commercial Distribution

  • H862CCL21050HBKS2 ()
  • H862CCL21050HBKS1 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
CCL2-1050HB-K

  • Biliary drain
HYDROPHILIC COATED BILIARY LOCKING CATHETER KIT WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
URESIL, LLC
CCL2-1050HB-K
In Commercial Distribution

  • H862CCL21050HBK2 ()
  • H862CCL21050HBK0 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
CCL2-1050HB-K

  • Biliary drain
Biliary "HB" Catheter + Fixation Kit - Locking - 8F 50
URESIL, LLC
CCL2-0850HB-KSA
Not in Commercial Distribution

  • H862CCL20850HBKSA2 ()
  • H862CCL20850HBKSA0 ()

  • Catheter Gauge: 8 French
  • Length: 41 Centimeter
CCL2-0850HB-KSA

  • Biliary drain
CHOLE-CATH Biliary Drainage Catheter Kit - 8F
URESIL, LLC
CCL2-0850HB-K
Not in Commercial Distribution

  • H862CCL20850HBKS2 ()
  • H862CCL20850HBKS1 ()

  • Catheter Gauge: 8 French
  • Length: 41 Centimeter
CCL2-0850HB-K

  • Biliary drain
HYDROPHILIC COATED BILIARY LOCKING CATHETER KIT WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
URESIL, LLC
CCL2-0850HB-K
In Commercial Distribution

  • H862CCL20850HBK2 ()
  • H862CCL20850HBK0 ()

  • Catheter Gauge: 8 French
  • Length: 41 Centimeter
CCL2-0850HB-K

  • Biliary drain
Dale IV Armor, Flexible protective overlay, Fits most.
Dale Medical Products, Inc.
675
In Commercial Distribution

  • H84106752 ()
  • H84106751 ()
675

  • Wearable percutaneous catheter/tube holder, non-sterile
Dale Bendable Armboard, X-Small, 4.25" x 1"
Dale Medical Products, Inc.
653
In Commercial Distribution

  • H84106532 ()
  • H84106531 ()
653

  • Armboard, reusable
Dale Bendable Armboard, Small, 4.5" x 1.75"
Dale Medical Products, Inc.
652
In Commercial Distribution

  • H84106522 ()
  • H84106521 ()
652

  • Armboard, reusable
Dale Bendable Armboard, Medium, 5.38" x 2.5"
Dale Medical Products, Inc.
651
In Commercial Distribution

  • H84106512 ()
  • H84106511 ()
651

  • Armboard, reusable
Dale Bendable Armboard, Large, 9" x 3.5"
Dale Medical Products, Inc.
650
In Commercial Distribution

  • H84106501 ()
  • H84106502 ()
650

  • Armboard, reusable
Dale Transducer Holder, Fits most
Dale Medical Products, Inc.
620
In Commercial Distribution

  • H84106202 ()
  • H84106201 ()
620

  • Electrode/transducer strap, single-use
Dale Nasal Dressing Holder, Fits most
Dale Medical Products, Inc.
600
In Commercial Distribution

  • H84106002 ()
  • H84106001 ()
600

  • Non-adhesive device retention bandage
Dale Urodynamic Tube Holder, Fits most
Dale Medical Products, Inc.
490
Not in Commercial Distribution

  • H84104902 ()
  • H84104901 ()
490

  • Urinary catheter holder
The Dale ENFit ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication while reducing the risk of potentially infectious splash back. The connector controls fluid flow into and out of most NG feeding tubes and other enteral tubes that use the ENFit connection system. The connector remains closed to the atmosphere, reducing the risk of cross contamination and eliminates mess and formula loss by maintaining a closed system (no disconnect). It has a simple ON/OFF handle and built in Needleless Syringe Port Seal which accepts most ENFit tip syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ENFit ACE Connector is DEHP free and not made with natural latex rubber.
Dale Medical Products, Inc.
485
In Commercial Distribution

  • H84104851 ()
  • H84104852 ()
485

  • Enteral feeding kit, adult/paediatric, sterile
The Dale ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication delivery while reducing the risk of potentially infectious splash back. The connector controls fluid flow into and out of most NG feeding tubes and other enteral tubes. The connector remains closed to the atmosphere, reducing the risk of cross contamination and eliminates mess and formula loss by maintaining a closed system (no disconnect). It has a simple ON/OFF handle and built in Needleless Syringe Port Seal which accepts most catheter tip 60 ml syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ACE Connector is DEHP free and not made with natural rubber latex.
Dale Medical Products, Inc.
475
In Commercial Distribution

  • H84104751 ()
  • H84104752 ()
475

  • Enteral feeding kit, adult/paediatric, sterile
Dale Foley Catheter Holder, Leg band / Waist band, fits up to 56"
Dale Medical Products, Inc.
330
In Commercial Distribution

  • H84103302 ()
  • H84103301 ()
330

  • Urinary catheter holder
Dale Foley Catheter Holder, Legband, fits up to 30"
Dale Medical Products, Inc.
316
In Commercial Distribution

  • H84103162 ()
  • H84103161 ()
316

  • Urinary catheter holder
Dale Endotracheal Tube Holder, Fits ET Tube sizes 7.0mm - 10.0mm
Dale Medical Products, Inc.
280
In Commercial Distribution

  • H84102802 ()
  • H84102801 ()
280

  • Endotracheal tube holder
Dale Adhesive Base for Dale 270 and 280
Dale Medical Products, Inc.
273
In Commercial Distribution

  • H84102732 ()
  • H84102731 ()
273

  • Endotracheal tube holder
Dale Endotracheal Tube Holder, Fits ET Tube sizes 7.0mm - 10.0mm
Dale Medical Products, Inc.
270
In Commercial Distribution

  • H84102702 ()
  • H84102701 ()
270

  • Endotracheal tube holder
Dale Bariatric Tracheostomy Tube Holder, 1.5" wide, fits up to 28" neck.
Dale Medical Products, Inc.
244
In Commercial Distribution

  • H84102442 ()
  • H84102441 ()
244

  • Tracheostomy tube neck holder, reusable
Dale PediPrints Tracheostomy Tube Holder, .75" wide, fits up to 9" neck.
Dale Medical Products, Inc.
242
In Commercial Distribution

  • H84102422 ()
  • H84102421 ()
242

  • Tracheostomy tube neck holder, reusable
Dale PediPrints Tracheostomy Tube Holder, 1" wide, fits up to 18" neck
Dale Medical Products, Inc.
241
In Commercial Distribution

  • H84102412 ()
  • H84102411 ()
241

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

  • H84101502 ()
  • H84101501 ()
150

  • Urinary catheter holder
Needle Sheath Prop
CERTOL INTERNATIONAL, LLC
PNS500
In Commercial Distribution

  • H816PNS5001 ()
  • H816PNS5000 ()
  • H816PNS5002 ()
PNS500-1

  • Surgical instrument containment holder, single-use, non-sterile
Needle Sheath Prop
CERTOL INTERNATIONAL, LLC
PNS100
In Commercial Distribution

  • H816PNS1002 ()
  • H816PNS1001 ()
  • H816PNS1000 ()
PNS100-1

  • Surgical instrument containment holder, single-use, non-sterile
Self-Sealing Sterilization Pouch/Packaging 7.5" x 13"
CERTOL INTERNATIONAL, LLC
PM7513
In Commercial Distribution

  • H816PM75132 ()
  • H816PM75131 ()
  • H816PM75130 ()
PM7513-1

  • Sterilization packaging, single-use
Self-Sealing Sterilization Pouch/Packaging 5.25" x 10"
CERTOL INTERNATIONAL, LLC
PM5410
In Commercial Distribution

  • H816PM54102 ()
  • H816PM54101 ()
  • H816PM54100 ()
PM5410-1

  • Sterilization packaging, single-use
Self-Sealing Sterilization Pouch/Packaging 3.5" x 9"
CERTOL INTERNATIONAL, LLC
PM3590
In Commercial Distribution

  • H816PM35902 ()
  • H816PM35901 ()
  • H816PM35900 ()
PM3590-1

  • Sterilization packaging, single-use
Self-Sealing Sterilization Pouch/Packaging 3.5" X 5.25"
CERTOL INTERNATIONAL, LLC
PM3554
In Commercial Distribution

  • H816PM35542 ()
  • H816PM35541 ()
  • H816PM35540 ()
PM3554-1

  • Sterilization packaging, single-use
Self Sealing Sterilization Pouch/Packaging 2 3/4" X 9"
CERTOL INTERNATIONAL, LLC
PM2790
In Commercial Distribution

  • H816PM27902 ()
  • H816PM27901 ()
  • H816PM27900 ()
PM2790-1

  • Sterilization packaging, single-use
Steam Sterilization Indicator Tape
CERTOL INTERNATIONAL, LLC
PIT340
In Commercial Distribution

  • H816PIT3401 ()
  • H816PIT3402 ()
PIT340-1

  • Sterilization packaging tape
Steam Sterilization Indicator Tape
CERTOL INTERNATIONAL, LLC
PIT120
In Commercial Distribution

  • H816PIT1201 ()
  • H816PIT1202 ()
PIT120-1

  • Sterilization packaging tape
Steam Sterilization Indicator Tape
CERTOL INTERNATIONAL, LLC
PIT100
In Commercial Distribution

  • H816PIT1002 ()
  • H816PIT1001 ()
PIT100-1

  • Sterilization packaging tape
High-Efficiency Face Mask w/ Earloop
CERTOL INTERNATIONAL, LLC
PFLEL8
In Commercial Distribution

  • H816PFLEL82 ()
  • H816PFLEL81 ()
  • H816PFLEL80 ()
PFLEL8-1

  • Surgical/medical face mask, single-use
High-Efficiency Face Mask with Headband
CERTOL INTERNATIONAL, LLC
PFL008
In Commercial Distribution

  • H816PFL0082 ()
  • H816PFL0081 ()
  • H816PFL0080 ()
PFL008-1

  • Surgical/medical face mask, single-use
Chemical Sterilant, Formaldehyde
MicroCare, LLC
VC338
In Commercial Distribution

  • H816MVC3381 ()
  • H816MVC3380 ()
  • H816VC3380 ()
VC338-1

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

  • H816MTSI4402 ()
  • H816MTSI4401 ()
  • H816MTSI4400 ()
  • H816TSI4401 ()
TSI440-1

  • Chemical/physical sterilization process indicator
Indicator Strips for Steam and Chemical Vapor
MicroCare, LLC
SM4340
In Commercial Distribution

  • H816MSM43402 ()
  • H816MSM43401 ()
  • H816MSM43400 ()
  • H816SM43401 ()
SM4340-1

  • Chemical/physical sterilization process indicator
Needle Sheath Prop
MicroCare, LLC
PNS500
In Commercial Distribution

  • H816MPNS5002 ()
  • H816MPNS5001 ()
  • H816MPNS5000 ()
  • H816PNS5001 ()
PNS500-1

  • Surgical instrument interim-placement holder, single-use
Self Sealing Sterilization Pouch, 7.5" x 13"
MicroCare, LLC
PM7513
In Commercial Distribution

  • H816MPM75132 ()
  • H816MPM75131 ()
  • H816MPM75130 ()
  • H816PM75131 ()
PM7513-1

  • Sterilization packaging, single-use
Self Sealing Sterilization Pouch, 5.25" x 10"
MicroCare, LLC
PM5410
In Commercial Distribution

  • H816MPM54102 ()
  • H816MPM54101 ()
  • H816MPM54100 ()
  • H816PM54101 ()
PM5410-1

  • Sterilization packaging, single-use
Self Sealing Sterilization Pouch, 3.5" x 9"
MicroCare, LLC
PM3590
In Commercial Distribution

  • H816MPM35902 ()
  • H816MPM35901 ()
  • H816MPM35900 ()
  • H816PM35901 ()
PM3590-1

  • Sterilization packaging, single-use
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