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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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Plasdent Clear Protection Sterilization Pouch - D832POH51410

Autoclave Pouches 5 1/4" x 10", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH514105 ()
  • D832POH51410 ()
  • D832POH514101 ()
  • D832POH514102 ()
POH514-10

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH312514

Autoclave Pouches 3 1/2" x 5 1/4", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH3125145 ()
  • D832POH312514 ()
  • D832POH3125141 ()
  • D832POH3125142 ()
POH312-514

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH2144

Autoclave Pouches 2 1/4" x 4", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH21445 ()
  • D832POH2144 ()
  • D832POH21441 ()
  • D832POH21442 ()
POH214-4

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH1215

Autoclave Pouches 12" x 15", Dual Indicator (100pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH12155 ()
  • D832POH1215 ()
  • D832POH12151 ()
  • D832POH12152 ()
POH12-15

  • Sterilization packaging, single-use

NSS IB-STIM - B960NSS203

The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
IB-STIM
In Commercial Distribution

  • B960NSS2031 ()
  • B960NSS203 ()
  • B960NSS2032 ()
  • B327NSS203 ()
  • B960NSS2033 ()
01-1020

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

NSS NeuroStim - B960NSS201

The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
NeuroStim
In Commercial Distribution

  • B960NSS201 ()
  • B960NSS2011 ()
  • B960NSS2012 ()
  • B327NSS201 ()
  • B960NSS2013 ()
01-1021

  • Acupuncture electrical stimulation system

NSS-2 Bridge - B960NSS200

The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination. NSS-2 BRIDGE stimulator is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS-2 BRIDGE stimulator is placed behind the patient’s ear and connected to stimulation needles on the auricle. NSS-2 BRIDGE stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
Bridge
In Commercial Distribution

  • B960NSS2001 ()
  • B960NSS200 ()
  • B960NSS2002 ()
  • B327NSS200 ()
  • B960NSS2003 ()
01-1017-NSS-2/BRIDGE

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

AuraLay XF Pit and Fissure Sealant - D820ALAYXFOW0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Opaque White
In Commercial Distribution

  • D820ALAYXFOW0 ()
  • D820ALAYXFOW3 ()
  • D820ALAYXFOW2 ()
  • D820ALAYXFOW1 ()
ALAYXFOW

  • Dental pit/fissure sealant

AuraLay XF Pit and Fissure Sealant - D820ALAYXFNT0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Natural Translucent
In Commercial Distribution

  • D820ALAYXFNT0 ()
  • D820ALAYXFNT3 ()
  • D820ALAYXFNT2 ()
  • D820ALAYXFNT1 ()
ALAYXFNT

  • Dental pit/fissure sealant

AuraLay Pit and Fissure Sealant - D820ALAYOW0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
Opaque White
In Commercial Distribution

  • D820ALAYOW0 ()
  • D820ALAYOW3 ()
  • D820ALAYOW2 ()
  • D820ALAYOW1 ()


  • Dental pit/fissure sealant

AuraLay Pit & Fissure Sealant - D820ALAYNT0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Natural Translucent
In Commercial Distribution

  • D820ALAYNT0 ()
  • D820ALAYNT1 ()
  • D820ALAYNT3 ()
  • D820ALAYNT2 ()
ALAYNT

  • Dental pit/fissure sealant

TriPhasix™ - M595S4000

1lb. TriPhasix™ Chromatic Alginate
PARKELL, INC.
S400
Not in Commercial Distribution

  • M595S4043 ()
  • M595S4000 ()
  • M595S4022 ()
  • M595S4011 ()
S400

  • Silicone dental impression material

Axiom® Lig-A-Loops® - M6651160

Retraction Tape, Mini, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
116
In Commercial Distribution

  • M6651165 ()
  • M6651163 ()
  • M6651161 ()
  • M6651160 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651140

Retraction Tape, Maxi, Blue, Veins
AXIOM MEDICAL, INCORPORATED
114
In Commercial Distribution

  • M6651145 ()
  • M6651143 ()
  • M6651141 ()
  • M6651140 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651130

Retraction Tape, Maxi, White, Nerves
AXIOM MEDICAL, INCORPORATED
113
In Commercial Distribution

  • M6651135 ()
  • M6651133 ()
  • M6651131 ()
  • M6651130 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651120

Retraction Tape, Maxi, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
112
In Commercial Distribution

  • M6651125 ()
  • M6651123 ()
  • M6651121 ()
  • M6651120 ()


  • Surgical support tape, non-bioabsorbable

Ch24 round silicone catheter - M640R99000990011

No Description
RAND SPA
001
In Commercial Distribution

  • M640R99000990012 ()
  • M640R99000990011 ()
  • M640R99000990013 ()
  • M640R99000990014 ()

  • Length: 600 Millimeter
  • Catheter Gauge: 24 French
R9900099

  • Multi-purpose percutaneous abdominothoracic drainage catheter

Axiom® Lig-A-Boots® - M6653010

Instrument Jaw Covers, Multi-Color Pack
AXIOM MEDICAL, INCORPORATED
301
In Commercial Distribution

  • M6653013 ()
  • M6653011 ()
  • M6653010 ()
  • M6653015 ()


  • Vascular booties

Axiom® Lig-A-Boots® - M6653000

Instrument Jaw Covers, White
AXIOM MEDICAL, INCORPORATED
300
In Commercial Distribution

  • M6653003 ()
  • M6653001 ()
  • M6653000 ()
  • M6653005 ()


  • Vascular booties

Axiom® Lig-A-Loops® - M6651180

Retraction Tape, Mini, Blue, Veins
AXIOM MEDICAL, INCORPORATED
118
In Commercial Distribution

  • M6651185 ()
  • M6651183 ()
  • M6651181 ()
  • M6651180 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651170

Retraction Tape, Mini, White, Nerves
AXIOM MEDICAL, INCORPORATED
117
In Commercial Distribution

  • M6651175 ()
  • M6651173 ()
  • M6651171 ()
  • M6651170 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651150

Retraction Tape, Mini, Red, Arteries
AXIOM MEDICAL, INCORPORATED
115
In Commercial Distribution

  • M6651155 ()
  • M6651153 ()
  • M6651151 ()
  • M6651150 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651110

Retraction Tape, Maxi, Red, Arteries
AXIOM MEDICAL, INCORPORATED
111
In Commercial Distribution

  • M6651115 ()
  • M6651113 ()
  • M6651111 ()
  • M6651110 ()


  • Surgical support tape, non-bioabsorbable

Ch24 round silicone catheter - M640R99000990001

No Description
RAND SPA
000
Not in Commercial Distribution

  • M640R99000990001 ()
  • M640R99000990002 ()
  • M640R99000990003 ()
  • M640R99000990004 ()

  • Length: 600 Millimeter
  • Catheter Gauge: 24 French
R9900099

  • Multi-purpose percutaneous abdominothoracic drainage catheter

FlexTube 3 single use - EFIAE0131041

The product is a single use navigated suction instrument for image guided surgical procedures. The instruments are intended as an aid for locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0131042 ()
  • EFIAE0131041 ()
  • EFIAE0131043 ()
  • EFIAE0131044 ()


  • ENT stereotactic surgery system

FlexPointer 1.5 single use - EFIAE0130041

The product FlexPointer 1.5 single use is navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0130041 ()
  • EFIAE0130042 ()
  • EFIAE0130043 ()
  • EFIAE0130044 ()
E 01 3004

  • ENT stereotactic surgery system

ERG-Jet - EFABF062

The ERG-Jet is a contact lens for performing an electroretinogram, or ERG, provocated by light stimulation of the retina in either humans or animals. The electrode is made of a gold ring just a few angstroms (10-10 meter) thick, which can be safely placed in contact with the cornea using a viscous conductive liquid.
Fabrinal SA
F06
In Commercial Distribution

  • EFABF061 ()
  • EFABF062 ()
  • EFAB0612 ()
  • EFABF063 ()

  • Electrical resistance: approx. 12 Ohms
  • Light transmission: 91.4%
  • Neutral optic quality
  • Female connection: DIN 1.50 Millimeter
  • Radius of curvature: 7.90 Millimeter
  • Outer Diameter: 12 Millimeter


  • Electroretinograph electrode

SPEAX Patch for Home Use - B792FGN010

Patch for use with the SPEAX Digital Communication System for Home Use
ATAIA INC.
FGN-010
In Commercial Distribution

  • B792FGN010 ()
  • B792FGN014 ()
  • B792FGN015 ()
  • B792FGN016 ()
FGN010

  • Voice amplification system

Glucertain - B492301500

Glucertain Blood Glucose Test Strips, 25/vial, 2 vials/box, 260 boxes/case
CELLERA LLC
30150
In Commercial Distribution

  • B492301500 ()
  • B492301501 ()
  • B492301502 ()
  • B492301503 ()
30150

  • Glucose IVD, kit, electrometry

Vitale - B492202340

Vitale Silicone Super-Absorbent Dressing, 3.5" x 4", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20234
Not in Commercial Distribution

  • B492202343 ()
  • B492202342 ()
  • B492202341 ()
  • B492202340 ()
20234

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492201660

Vitale Silicone Foam Dressings, 6"x6", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20166
Not in Commercial Distribution

  • B492201663 ()
  • B492201661 ()
  • B492201660 ()
  • B492201662 ()
20166

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492201440

Vitale Silicone Foam Dressings, 4"x4", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20144
Not in Commercial Distribution

  • B492201440 ()
  • B492201441 ()
  • B492201442 ()
  • B492201443 ()
20144

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492200660

Vitale Silicone Foam Dressings with Antibacterial Silver, 6"x6", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20066
In Commercial Distribution

  • B492200663 ()
  • B492200662 ()
  • B492200661 ()
  • B492200660 ()
20066

  • Exudate-absorbent dressing, non-gel, antimicrobial

Vitale - B492200440

Vitale Silicone Foam Dressings with Antibacterial Silver, 4"x4", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20044
In Commercial Distribution

  • B492200442 ()
  • B492200441 ()
  • B492200440 ()
  • B492200443 ()
20044

  • Exudate-absorbent dressing, non-gel, antimicrobial

DIASOL - B467BP4525

Diasol Sodium Bicarbonate Powder
DIASOL, INC.
BP10000- 25G / x25T
In Commercial Distribution

  • B467BP4525 ()
  • B467BP4525G3 ()
  • B467BP4524T2 ()
  • B4674525T1 ()
BP2/3 - BP9/10

  • Haemodialysis concentrate

DRYASOL - B467ACP4522575100

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45225-75100
In Commercial Distribution

  • B467ACP452257510016 ()
  • B467ACP4522575100 ()
  • B467ACP452257510020 ()
  • B467ACP452257510025 ()
ACP8/9/10

  • Haemodialysis concentrate

Environ-mate - B325PT20C101

Polyp Trap with screw top, fine-mesh screen and tube with connector.. Package of 10.
M D Technologies Inc.
PT20C-10
In Commercial Distribution

  • B325PT20C100 ()
  • B325PT20C101 ()
  • B325PT20C252 ()
  • B325PT20C503 ()
  • B325PT20C1004 ()
PT20C10

  • Surgical suction system collection container, single-use

Environ-mate - B325PT20101

Polyp Trap with screw top, fine-mesh screen and plain tube. Package of 10.
M D Technologies Inc.
PT20-10
In Commercial Distribution

  • B325PT20252 ()
  • B325PT20100 ()
  • B325PT20503 ()
  • B325PT201004 ()
  • B325PT20101 ()
PT2010

  • Surgical suction system collection container, single-use

Easy Glide 3cc Luer Lock Syringe - B2086730300

Easy Glide 3cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
673030
In Commercial Distribution

  • B2086730303 ()
  • B2086730301 ()
  • B2086730300 ()
  • B2086730304 ()


  • General-purpose syringe, single-use

Easy Glide 10cc Luer Lock Syringe - B2086710200

Easy Glide 10cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
671020
In Commercial Distribution

  • B2086710203 ()
  • B2086710201 ()
  • B2086710200 ()
  • B2086710204 ()


  • General-purpose syringe, single-use
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