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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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Sohn's Dilators - 00861838000323

Dilators used for the treatment of anal fissure.
TOOLS FOR SURGERY, LLC
SOD-03
In Commercial Distribution

  • 00861838000323 ()

  • Outer Diameter: 40 Millimeter
  • Outer Diameter: 35 Millimeter
  • Outer Diameter: 30 Millimeter
SOD-03

  • Rectal dilator, reusable

Hemorrhage Occluder Pin with Applicator - 00861838000316

Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery. Also available with applicator.
TOOLS FOR SURGERY, LLC
HOP-AP
In Commercial Distribution

  • 00861838000316 ()

  • Length: 7 Millimeter
  • Outer Diameter: 10 Millimeter
HOP-AP

  • Skin stapler/staple, non-bioabsorbable

Hemorrhage Occluder Pin - 00861838000309

Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery.
TOOLS FOR SURGERY, LLC
HOP-03
In Commercial Distribution

  • 00861838000309 ()

  • Length: 7 Millimeter
  • Outer Diameter: 10 Millimeter
HOP-03

  • Skin stapler/staple, non-bioabsorbable

CorVista® System with PH Add-On - 00869059000443

CorVista System with PH Add-On
Analytics for Life Inc.
CorVista System with PH Add-On
In Commercial Distribution

  • 00869059000443 ()


  • Multiparameter physiologic analysis workstation

CorVista® System with CAD Add-On - 00869059000436

CorVista System with CAD Add-On
Analytics for Life Inc.
CorVista System with CAD Add-On
In Commercial Distribution

  • 00869059000436 ()


  • Multiparameter physiologic analysis workstation

CorVista® System - 00869059000429

CorVista® System with CAD Add-On
Analytics for Life Inc.
10-0020
In Commercial Distribution

  • 00869059000429 ()


  • Multiparameter physiologic analysis workstation

HemoBand - 00865165000223

HemoBand Sterile HB-1M (Standard Length - 14")
INNOVATIONS FOR ACCESS INC
HB-1M
In Commercial Distribution

  • 00865165000223 ()

  • Length: 14 Inch
HB-1M

  • Vascular puncture haemostasis arm clamp/band, single-use

HemoBand - 00865165000216

HemoBand Non-Sterile HB-NS (Standard Length - 14")
INNOVATIONS FOR ACCESS INC
HB-NS
In Commercial Distribution

  • 00865165000216 ()

  • Length: 14 Inch
HB-NS

  • Vascular puncture haemostasis arm clamp/band, single-use

HemoBand - 00865165000209

HemoBand Non-Sterile XL HB-NSXL (Extra Long Length - 17")
INNOVATIONS FOR ACCESS INC
HB-NSXL
In Commercial Distribution

  • 00865165000209 ()

  • Length: 17 Inch
HB-NSXL

  • Vascular puncture haemostasis arm clamp/band, single-use

SIREN SGT - 00860002701363

Suction-regulated orogastric calibration tube, 36 Fr
TOOLS FOR SURGERY, LLC
SGT-36
In Commercial Distribution

  • 00860002701363 ()

  • Outer Diameter: 12 Millimeter
SGT-36

  • Nasogastric/orogastric tube

Barbell Loop Ostomy Device - 00860002701325

Loop Ostomy Device, Small (2-inch rod).
TOOLS FOR SURGERY, LLC
BAR-2
In Commercial Distribution

  • 00860002701325 ()

  • Length: 2 Inch
BAR-2

  • Colostomy rod

Bariatric Air Syringe - 00861838000378

Expedite and standardize the 'bubble test' for gastrojejunal anastomoses and sleeve gastrectomy.
TOOLS FOR SURGERY, LLC
ALT-BA
In Commercial Distribution

  • 00861838000378 ()

  • Length: 6.76 Inch
ALT-BA

  • Endoscope inflation bulb

SPEAK FOR LESS - 05070003548507

An antistammering device intended to help individuals who stutter improve their level of fluency. The device modifies how users hear their own voice, supporting smoother and more controlled speech patterns by using Delayed Auditory Feedback (DAF) technology with a 70-millisecond time delay.
SPEAK FOR LESS LTD
FP-A01
In Commercial Distribution

  • 05070003548507 ()
  • 15070003548504 ()
  • 25070003548501 ()
  • 35070003548508 ()
  • 45070003548505 ()
  • 55070003548502 ()
  • 65070003548509 ()
  • 75070003548506 ()
  • 85070003548503 ()


  • Antistammering device

Hyperbaric for Life - G625R800340

Hyperbaric Chamber
Hyperbaric For Life.com, Llc
8003
In Commercial Distribution

  • G625R800340 ()


  • Hyperbaric chamber, stationary

a-Amylase EPS ver.2 - 07613336121009

No Description
Roche Diagnostics GmbH
08056811190
In Commercial Distribution

  • 07613336121009 ()
08056811190

  • Total amylase IVD, kit, spectrophotometry

AMYP Amylase EPS Pancreatic - 04015630913893

No Description
Roche Diagnostics GmbH
20766623322
In Commercial Distribution

  • 04015630913893 ()
20766623322

  • Amylase isoenzyme IVD, kit, spectrophotometry

alpha-Amylase EPS ver.2 - 04015630926886

No Description
Roche Diagnostics GmbH
5401496190
In Commercial Distribution

  • 04015630926886 ()
5401496190

  • Total amylase IVD, kit, spectrophotometry

alpha-Amylase EPS ver.2 - 04015630924875

No Description
Roche Diagnostics GmbH
5167027190
In Commercial Distribution

  • 04015630924875 ()
5167027190

  • Total amylase IVD, kit, spectrophotometry

Memodyn staples - 03615390002786

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU99
In Commercial Distribution

  • 03615390002786 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002779

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU88
In Commercial Distribution

  • 03615390002779 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002762

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU751.2X1.2
In Commercial Distribution

  • 03615390002762 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002755

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU2020
In Commercial Distribution

  • 03615390002755 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002748

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU2015
In Commercial Distribution

  • 03615390002748 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002731

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU1610
In Commercial Distribution

  • 03615390002731 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002724

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU1515
In Commercial Distribution

  • 03615390002724 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002717

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU1410
In Commercial Distribution

  • 03615390002717 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002700

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU1210
In Commercial Distribution

  • 03615390002700 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002694

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU12(1315)
In Commercial Distribution

  • 03615390002694 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002687

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU1110
In Commercial Distribution

  • 03615390002687 ()


  • Orthopaedic bone staple, non-adjustable

Memodyn staples - 03615390002670

BIPOD SHAPE MEMORY STAPLE
GROUPE LEPINE
CSU1010
In Commercial Distribution

  • 03615390002670 ()


  • Orthopaedic bone staple, non-adjustable

NA - 07613153157922

FORCEPS, JANSEN, BAYONET SHAPE
Stryker Leibinger GmbH & Co. KG
31-19625
In Commercial Distribution

  • 07613153157922 ()

  • Length: 20.0 Centimeter
31-19625

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Real Shades - 00811186017382

Heart Shape Style Sunglasses
Slp Enterprises, LLC
Heart
In Commercial Distribution

  • 00811186017382 ()


  • Tinted non-prescription spectacles

Real Shades - 00811186017375

Star Shape Style Sunglasses
Slp Enterprises, LLC
Star
In Commercial Distribution

  • 00811186017375 ()


  • Tinted non-prescription spectacles

RETRACTOR - 00888118128522

ROUX, IOWA, S SHAPE
KLS-Martin L.P.
15-669-12-01
In Commercial Distribution

  • 00888118128522 ()


  • Hand-held dental retractor

Avalign - 00190776210038

Haight Retractor T shape
Avalign Technologies, Inc.
VM71-2323
In Commercial Distribution

  • 00190776210038 ()


  • Hand-held surgical retractor, reusable

Avalign - 00190776057183

Haight Retractor "T" shape
Avalign Technologies, Inc.
VM71-2322
In Commercial Distribution

  • 00190776057183 ()


  • Hand-held surgical retractor, reusable

Avalign - 00190776057176

Haight Retractor "T" shape
Avalign Technologies, Inc.
VM71-2321
In Commercial Distribution

  • 00190776057176 ()


  • Hand-held surgical retractor, reusable

ASSI - 00841645109815

Abrasive Stone Rectangular Shape
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.AR68
In Commercial Distribution

  • 00841645109815 ()


  • Surgical instrument/implant rack

INTEGRA® - 00650551096368

TISSUE EXPANDER, ECLIPSE SHAPE
PMT CORPORATION
3611-637
In Commercial Distribution

  • 00650551096368 ()

  • Projection 1 Centimeter
  • Total Volume: 8 Centiliter
  • Length: 1 Centimeter
  • Width: 0.5 Centimeter
3611-637

  • Skin-port tissue expander

NORDENT MANUFACTURING INC - 00840018631571

EXCAVATOR 18 OVAL SHAPE
NORDENT MANUFACTURING INC
EC18W
In Commercial Distribution

  • 00840018631571 ()


  • Dental excavator, reusable

NORDENT MANUFACTURING INC - 00840018631557

EXCAVATOR 17 OVAL SHAPE
NORDENT MANUFACTURING INC
EC17W
In Commercial Distribution

  • 00840018631557 ()


  • Dental excavator, reusable

NORDENT MANUFACTURING INC - 00840018647985

EXCAVATOR 17 OVAL SHAPE
NORDENT MANUFACTURING INC
REEC17W
In Commercial Distribution

  • 00840018647985 ()


  • Dental excavator, reusable

Piranha - 00024291529873

CLIP ON SHAPE 7
Navajo Manufacturing Company
52987
In Commercial Distribution

  • 00024291529873 ()


  • Tinted non-prescription spectacles

Piranha - 00024291529866

CLIP ON SHAPE 6
Navajo Manufacturing Company
52986
In Commercial Distribution

  • 00024291529866 ()


  • Tinted non-prescription spectacles

Piranha - 00024291529859

CLIP ON SHAPE 5
Navajo Manufacturing Company
52985
In Commercial Distribution

  • 00024291529859 ()


  • Tinted non-prescription spectacles

Piranha - 00024291529842

CLIP ON SHAPE 4
Navajo Manufacturing Company
52984
In Commercial Distribution

  • 00024291529842 ()


  • Tinted non-prescription spectacles

Piranha - 00024291529835

CLIP ON SHAPE 3
Navajo Manufacturing Company
52983
In Commercial Distribution

  • 00024291529835 ()


  • Tinted non-prescription spectacles

Piranha - 00024291529828

CLIP ON SHAPE 2
Navajo Manufacturing Company
52982
In Commercial Distribution

  • 00024291529828 ()


  • Tinted non-prescription spectacles

Piranha - 00024291529811

CLIP ON SHAPE 1
Navajo Manufacturing Company
52981
In Commercial Distribution

  • 00024291529811 ()


  • Tinted non-prescription spectacles

Symmetry Classic® DEBAKEY - 00887482011010

Vascular Clamp S Shape
SYMMETRY SURGICAL INC.
37-1115
In Commercial Distribution

  • 00887482011010 ()
37-1115

  • Clamp manipulation forceps
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