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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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Critical Cover - 10817583023039

Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, XL
Alpha Pro Tech, Inc.
MS-01J06-4
In Commercial Distribution

  • 20817583023036 ()
  • 10817583023039 ()
  • 00817583023032 ()
MS-01J06-4

  • Surgical sleeve cover

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

Hayden Medical - 00840319739730

Potts-Smith Dressing Forceps 12" (30cm), serrated, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-159NC
In Commercial Distribution

  • 00840319739730 ()
120-159NC

  • Dressing/utility forceps, tweezers-like, reusable

Hayden Medical - 00840319739358

Tissue Forceps 8" (20cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-048NC
In Commercial Distribution

  • 00840319739358 ()
120-048NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Aero-Med - 10885380181207

Swab Saline At Home Collection and Transport Kit, Cleveland Clinic Only
AERO-MED, LLC
CA33575
In Commercial Distribution

  • 50885380181205 ()
  • 10885380181207 ()
CA33575

  • Specimen mailer kit

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

TRUE METRIX AIR - 00311917173894

Well at Walgreens TRUE METRIX AIR self monitoring blood glucose meter
TRIVIDIA HEALTH, INC.
TRUE METRIX AIR self monitoring blood glucose meter
In Commercial Distribution

  • 10311917173891 ()
  • 00311917173894 ()
  • 00021292007720 ()
REA4001-01

  • Glucose monitoring system IVD, home-use

Millennium - 00190776374518

Oral Surgery Rongeur, #4A, 6 1/2", jaws at 35deg angle
Avalign Technologies, Inc.
1-22488
In Commercial Distribution

  • 00190776374518 ()


  • Dental rongeur

MasterPeace - 07350121950566

Table Shield. To be placed at the foot end of table
Texray AB
Table Shield End
In Commercial Distribution

  • 07350121950566 ()

  • Width: 90 Centimeter
  • Length: 80 Centimeter
TS3050

  • Radiation shielding table drape

Integra® Ruggles®-Redmond™ - 10381780194446

John Day Periosteal Elevator, 8", Angled 30° At Cup, 6mm Cup
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
R8907
Not in Commercial Distribution

  • M274R89071 ()
  • 10381780194446 ()
R8907

  • Neurosurgical bone flap elevator

BOSS Instruments - 00888515027725

Seletz Gelpi Ret, arms bent at rt ang, 6 3/4"
BOSS INSTRUMENTS, LTD., INC.
18-3100
In Commercial Distribution

  • 00888515027725 ()
18-3100

  • Self-retaining surgical retractor, reusable

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

HELMUT ZEPF - EZPF50229160

PLIERS, OPERATIVE DEBAKEY AT FCPS/PLIERS OPERATIVE,MODIF. 16 CM, ANGELED
Helmut Zepf Medizintechnik GmbH
50.229.16
In Commercial Distribution

  • EZPF50229160 ()
50.229.16

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Accu-Beam - B1770966060

Re-usable fiberoptic handpiece for lasers. 400mm, double bend at handle & tip.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
096606
In Commercial Distribution

  • B1770966060 ()


  • General/multiple surgical laser system beam guide, reusable

Life Instruments - M930712013013900

American Rainbow Curette#3/0 Ang 90deg at 2mm from Cup
Life Instrument Corporation
712-0130-1-3-90
In Commercial Distribution

  • M930712013013900 ()


  • Bone curette, reusable

Duality - 08059173396368

Dermatological and aesthetic laser device operating at 1064 and 532 nm.
QUANTA SYSTEM SPA
PCMS00354
In Commercial Distribution

  • 08059173396368 ()


  • Dermatological frequency-doubled solid-state laser system

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
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