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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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Circular Stapler Anvil Sizer Set - 00860002701387

Circular Stapler Anvil Sizer Set includes (1) 25 mm, (1) 29 mm, and (1) 33 mm reusable anvil sizers that are used to assist in choosing surgical stapler size.
TOOLS FOR SURGERY, LLC
ANS-10
In Commercial Distribution

  • 00860002701387 ()
ANS-10

  • Colorectal sizer

Barbell Loop Ostomy Device - 00860002701356

Loop Ostomy Device, Large (4-inch rod).
TOOLS FOR SURGERY, LLC
BAR-4
In Commercial Distribution

  • 00860002701356 ()

  • Length: 4 Inch
BAR-4

  • Colostomy rod

Barbell Loop Ostomy Device - 00860002701349

Loop Ostomy Device, Medium (3-inch rod).
TOOLS FOR SURGERY, LLC
BAR-3
In Commercial Distribution

  • 00860002701349 ()

  • Length: 3 Inch
BAR-3

  • Colostomy rod

Colorectal Air Syringe-LP EX - 00860002701332

Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes 3 extender tips.
TOOLS FOR SURGERY, LLC
ALT-50EX
In Commercial Distribution

  • 00860002701332 ()

  • Length: 8.5 Inch
ALT-50EX

  • Endoscope inflation bulb

Colorectal Air Syringe-OP EX - 00860002701318

Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes 3 extender tips.
TOOLS FOR SURGERY, LLC
ALT-30EX
In Commercial Distribution

  • 00860002701318 ()

  • Length: 8.5 Inch
ALT-30EX

  • Endoscope inflation bulb

DIABIMETRICS Blood Glucose Test Strips (50PCS) - 00860009958029

No Description
Health For Mankind Company
TD-4143
In Commercial Distribution

  • 00860009958029 ()


  • Glucose IVD, kit, electrometry

DIABIMETRICS Blood Glucose Monitoring System - 00860009958012

Meter*1 Lancing Device*1 Sterile Lancets*10
Health For Mankind Company
TD-4143
In Commercial Distribution

  • 00860009958012 ()


  • Glucose monitoring system IVD, home-use

Precision for Medicine Convenience Kit - 00860006973520

No Description
Precision For Medicine, Inc.
001
In Commercial Distribution

  • 00860006973520 ()


  • General specimen collection kit IVD, clinical

Colorectal Air Syringe-LP - 00861838000361

Expedite and standardize the 'bubble test' for colorectal anastomoses.
TOOLS FOR SURGERY, LLC
ALT-50
In Commercial Distribution

  • 00861838000361 ()

  • Length: 8.7 Inch
ALT-50

  • Endoscope inflation bulb

Colorectal Air Syringe-OP - 00861838000354

Expedite and standardize the 'bubble test' for colorectal anastomoses.
TOOLS FOR SURGERY, LLC
ALT-30
In Commercial Distribution

  • 00861838000354 ()

  • Length: 8.5 Inch
ALT-30

  • Endoscope inflation bulb

WIKI Drain, 15 Fr, 3 cm, 6 Drains - 00861838000347

The WIKI Drain is a flanged quadruple-lumen silicone channel drain. Package contains 6, 15 Fr, 3 cm drains.
TOOLS FOR SURGERY, LLC
WIK-15-3-6
In Commercial Distribution

  • 00861838000347 ()

  • Outer Diameter: 5 Millimeter
  • Length: 3 Centimeter
WIK-15-3-6

  • Surgical capillary wound drain, non-luminal

WIKI Drain, 15 Fr, 3 cm, 1 Drain - 00861838000330

The WIKI Drain™ is a flanged quadruple-lumen silicone channel drain. Package of 1, 15 Fr, 3 cm drain.
TOOLS FOR SURGERY, LLC
WIK-15-3-1
In Commercial Distribution

  • 00861838000330 ()

  • Outer Diameter: 5 Millimeter
  • Length: 3 Centimeter
WIK-15-3-1

  • Surgical capillary wound drain, non-luminal

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
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