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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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Critica Cover - 10817583023015

Sleeve Protector, NuTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01606-8
In Commercial Distribution

  • 20817583023012 ()
  • 10817583023015 ()
  • 00817583023018 ()
MS-01606-8

  • Surgical sleeve cover

Critical Cover - 10817583023008

Sleeve Protector, NuTech, White, Sonic Welded, Elastic at both ends, XL
Alpha Pro Tech, Inc.
MS-01606-4
In Commercial Distribution

  • 20817583023005 ()
  • 10817583023008 ()
  • 00817583023001 ()
MS-01606-4

  • Surgical sleeve cover

Critical Cover - 10817583022995

Sleeve Protector, GenPro, White, Serged Seams, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01135-8
In Commercial Distribution

  • 20817583022992 ()
  • 10817583022995 ()
  • 00817583022998 ()
MS-01135-8

  • Surgical sleeve cover

Surgical Direct - B382SD209590

3.4mm Arthroscopic Sidebiter, 90 Degrees angled at tip, Left, without scoop
Surgical Direct, Inc.
SD20959
In Commercial Distribution

  • B382SD209590 ()
SD20959

  • Endoscope sheath, reusable

Surgical Direct - B382SD208590

3.4mm Arthroscopic Sidebiter, 90 Degree angled at tip, left with scoop
Surgical Direct, Inc.
SD20859
In Commercial Distribution

  • B382SD208590 ()
SD20859

  • Endoscope sheath, reusable

Surgical Direct - B382SD208090

3.4mm Arthroscopic Sidebiter, 90 Degree angled at tip, Right, with Scoop
Surgical Direct, Inc.
SD20809
In Commercial Distribution

  • B382SD208090 ()
SD20809

  • Endoscope sheath, reusable

Aero-Med - 10885380176166

Blood Culture Collection Kit, Robert Wood Johnson at New Brunswick Only
AERO-MED, LLC
CA10875
In Commercial Distribution

  • 50885380176164 ()
  • 10885380176166 ()
CA10875

  • Phlebotomy kit

Resp-O2 50 PSI Compressor - 00840117324008

Voltage: AC 110-120V 60Hz, Max pressure: 95 psi (preset), Air flow at 0 psi: ~37 l/min, Air flow at 50 psi: ~17 l/min
Dynarex Corporation
33952
In Commercial Distribution

  • 00840117324008 ()
  • 00840117327498 ()


  • Medical device air compressor

NA - 10858512007041

Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-2
In Commercial Distribution

  • 30858512007045 ()
  • 10858512007041 ()

  • Total Volume: 30 Milliliter
303-2

  • Multiple urine analyte IVD, control

NA - 10858512007034

Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-1
In Commercial Distribution

  • 10858512007034 ()
  • 30858512007038 ()

  • Total Volume: 30 Milliliter
303-1

  • Multiple urine analyte IVD, control

NA - 10858512007010

Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-2
In Commercial Distribution

  • 30858512007014 ()
  • 10858512007010 ()

  • Total Volume: 20 Milliliter
301-2

  • Multiple urine analyte IVD, control

NA - 10858512007003

Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-1
In Commercial Distribution

  • 30858512007007 ()
  • 10858512007003 ()

  • Total Volume: 20 Milliliter
301-1

  • Multiple urine analyte IVD, control

MR PHACO - G412PH9517T0

Toric IOL Reference Marker Blades are positioned at 0, 90, 180 Degrees, Head is angled at 70 degrees, Round Knurled Handle, 98mm Overall Length, Titanium
Crestpoint Management Limited
PH9517T
In Commercial Distribution

  • G412PH9517T0 ()


  • Corneal marker, reusable

Medetz Surgical Instruments - G223928400

Toric IOL Reference Marker Blades are positioned at 0, 90, 180 Degrees, Head is angled at 70 degrees, Round Knurled Handle, 98mm Overall Length, Stainless Steel
Medetz Surgical Instruments LLC
92-840
In Commercial Distribution

  • G223928400 ()


  • Corneal marker, reusable

MR PHACO - G412PH95170

Toric IOL Reference Marker Blades are positioned at 0, 90, 180 Degrees, Head is angled at 70 degrees, Round Knurled Handle, 98mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH9517
In Commercial Distribution

  • G412PH95170 ()


  • Corneal marker, reusable

Esophageal TTS Stent - 08809744973500

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2215B-22
In Commercial Distribution

  • 08809744973500 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 15 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973494

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2214B-22
In Commercial Distribution

  • 08809744973494 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 14 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973487

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2212B-22
In Commercial Distribution

  • 08809744973487 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 12 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973470

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2210B-22
In Commercial Distribution

  • 08809744973470 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 10 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973463

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2208B-22
In Commercial Distribution

  • 08809744973463 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 8 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973456

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2206B-22
In Commercial Distribution

  • 08809744973456 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 6 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973449

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2015B-22
In Commercial Distribution

  • 08809744973449 ()

  • Stent Diameter: 20 Millimeter
  • Stent Length: 15 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973432

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2014B-22
In Commercial Distribution

  • 08809744973432 ()

  • Stent Diameter: 20 Millimeter
  • Stent Length: 14 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973425

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2012B-22
In Commercial Distribution

  • 08809744973425 ()

  • Stent Diameter: 20 Millimeter
  • Stent Length: 12 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973418

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2010B-22
In Commercial Distribution

  • 08809744973418 ()

  • Stent Diameter: 20 Millimeter
  • Stent Length: 10 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973401

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2008B-22
In Commercial Distribution

  • 08809744973401 ()

  • Stent Diameter: 20 Millimeter
  • Stent Length: 8 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973395

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2006B-22
In Commercial Distribution

  • 08809744973395 ()

  • Stent Diameter: 20 Millimeter
  • Stent Length: 6 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973388

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST1815B-22
In Commercial Distribution

  • 08809744973388 ()

  • Stent Diameter: 18 Millimeter
  • Stent Length: 15 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973371

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST1814B-22
In Commercial Distribution

  • 08809744973371 ()

  • Stent Diameter: 18 Millimeter
  • Stent Length: 14 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent

Esophageal TTS Stent - 08809744973357

Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST1810B-22
In Commercial Distribution

  • 08809744973357 ()

  • Stent Diameter: 18 Millimeter
  • Stent Length: 10 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent
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