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

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


  • Surgical support tape, non-bioabsorbable
Retraction Tape, Mini, Red, Arteries
AXIOM MEDICAL, INCORPORATED
115
In Commercial Distribution

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


  • Surgical support tape, non-bioabsorbable
Retraction Tape, Maxi, Red, Arteries
AXIOM MEDICAL, INCORPORATED
111
In Commercial Distribution

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


  • Surgical support tape, non-bioabsorbable
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
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
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
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
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 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 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 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 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 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 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 Sodium Bicarbonate Powder
DIASOL, INC.
BP10000- 25G / x25T
In Commercial Distribution

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

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

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

  • Haemodialysis concentrate
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
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
GLOBAL DIABETIC DISTRIBUTORS INC
673030
In Commercial Distribution

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


  • General-purpose syringe, single-use
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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