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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Curved Jaw Cordless Ultrasonic Dissector
Covidien LP
SCD7A13
In Commercial Distribution

  • 20884521794778 ()
  • 10884521794771 ()

  • Length: 13 Centimeter


  • Soft-tissue ultrasonic surgical system
2de12 4-0 Pdo 7 X 7
Surgical Specialties México, S. de R.L. de C.V.
RA-1012Q
In Commercial Distribution

  • 10848782018526 ()
  • 00848782018529 ()

  • 4-0 USP


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
2stc8 -1- Pdo 7 X 7
Surgical Specialties México, S. de R.L. de C.V.
RA-1024Q
In Commercial Distribution

  • 10848782018731 ()
  • 00848782018734 ()

  • 1 USP


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
2de11 3-0 Pdo 7 X 7
Surgical Specialties México, S. de R.L. de C.V.
RA-1017Q
In Commercial Distribution

  • 10848782018618 ()
  • 00848782018611 ()

  • 3-0 USP


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
2de12 4-0 Pdo 7 X 7
Surgical Specialties México, S. de R.L. de C.V.
RA-1012Q-0
In Commercial Distribution

  • 10848782018533 ()
  • 00848782018536 ()

  • 4-0 USP


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
2de12 3-0 Pdo 7 X 7
Surgical Specialties México, S. de R.L. de C.V.
RA-1010Q
In Commercial Distribution

  • 10848782018502 ()
  • 00848782018505 ()

  • 3-0 USP


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Plak-Vac custom kit
TRADEMARK MEDICAL, L.L.C.
3035
In Commercial Distribution

  • B23930351 ()
  • B23930350 ()
3035

  • Oral care kit, single-use
Plak-Vac custom kit
TRADEMARK MEDICAL, L.L.C.
2413
In Commercial Distribution

  • B23924131 ()
  • B23924130 ()
2413

  • Oral care kit, single-use
Plak-Vac custom kit
TRADEMARK MEDICAL, L.L.C.
2405
In Commercial Distribution

  • B23924050 ()
  • B23924051 ()
2405

  • Oral care kit, single-use
Universal Strip Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4302
In Commercial Distribution

  • 00850015266935 ()


  • Patient monitoring system module, electroencephalographic
Single-Use Strip Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4301
In Commercial Distribution

  • 00850015266614 ()


  • Patient monitoring system module, electroencephalographic
Small 10-20 Single-Use Strip Kit (Qty 5)
ADVANCED BRAIN MONITORING, INC.
XS30-4211.5
In Commercial Distribution

  • 00850015266324 ()


  • Patient monitoring system module, electroencephalographic
Small 10-20 Single-Use Strip Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4211
In Commercial Distribution

  • 00850015266300 ()


  • Patient monitoring system module, electroencephalographic
X-Small 10-20 Single-Use Strip Kit (Qty 2)
ADVANCED BRAIN MONITORING, INC.
XS30-4210.2
In Commercial Distribution

  • 00850015266423 ()


  • Patient monitoring system module, electroencephalographic
Medium 10-20 Single-Use Strip Kit (Qty 5)
ADVANCED BRAIN MONITORING, INC.
XS30-4212.5
In Commercial Distribution

  • 00850015266331 ()


  • Patient monitoring system module, electroencephalographic
Medium 10-20 Single-Use Strip Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4212
In Commercial Distribution

  • 00850015266317 ()


  • Patient monitoring system module, electroencephalographic
X24 Disposable Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS24-4321
In Commercial Distribution

  • 00851113007895 ()


  • Analytical scalp electrode, single-use
X10 Disposable Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS10-4321
In Commercial Distribution

  • 00851113007888 ()


  • Analytical scalp electrode, single-use
Synapse Cream Kit
ADVANCED BRAIN MONITORING, INC.
XS02-4351
In Commercial Distribution

  • 00851113007451 ()


  • Electrode conductive medium
Placeholder film for dental film impressions
bisico Bielefelder Dentalsilicone GmbH & Co. KG
03910
In Commercial Distribution

  • EBIB039101 ()
03910

  • Wax dental impression material
FluoroPerm® 151 (paflufocon D) rigid gas permeable contact lenses for daily wear and extended wear are available as lathe cut or molded firm contact lenses with spherical front and back surfaces in tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The FluoroPerm® 151 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 151 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 151
In Commercial Distribution

  • B22207 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. FluoroPerm® 60 rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The FluoroPerm® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 60 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 60
In Commercial Distribution

  • B22205 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
FluoroPerm® 92 (paflufocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric,bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. FluoroPerm 92 rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The FluoroPerm® 92 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 92 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 92
In Commercial Distribution

  • B22204 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
Paraperm® EW (pasifocon C) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. Paraperm® EW rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The Paraperm® EW rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The Paraperm® EW rigid gas permeable tinted lenses offer a handling aid for locating the lens.
Paragon Vision Sciences, Inc.
Paraperm EW
In Commercial Distribution

  • B22203 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
No Description
MENICON CO.,LTD.
Wine Red
In Commercial Distribution

  • 00192538901086 ()


  • Orthokeratology contact lens
  • Rigid-gas-permeable corrective contact lens, extended-wear
No Description
MENICON CO.,LTD.
Pale yellow
In Commercial Distribution

  • 00884465092011 ()


  • Rigid-gas-permeable corrective contact lens, extended-wear
  • Rigid-gas-permeable corrective contact lens, daily-wear
No Description
MENICON CO.,LTD.
Blue
In Commercial Distribution

  • 00884465091014 ()


  • Rigid-gas-permeable corrective contact lens, extended-wear
  • Rigid-gas-permeable corrective contact lens, daily-wear
Rigid Gas Permeable Contact Lens
Bausch & Lomb Incorporated
oprifocon A
In Commercial Distribution

  • 00785811435639 ()
Boston Equalens II

  • Rigid-gas-permeable corrective contact lens, extended-wear
  • Orthokeratology contact lens
No Description
Terumo Cardiovascular Systems Corporation
66813
In Commercial Distribution

  • 50699753511595 ()
  • 00699753511590 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
Terumo Cardiovascular Systems Corporation
66829
In Commercial Distribution

  • 50699753512523 ()
  • 00699753512528 ()


  • Cardiopulmonary bypass system blood tubing set
WEDGE, 7" x 7" x 7"
DOMICO MED-DEVICE, LLC
118-8
In Commercial Distribution

  • 00810050245036 ()

  • Height: 7 Inch
  • Width: 7 Inch
  • Length: 7 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
WEDGE, 7” x 7” x 7”
DOMICO MED-DEVICE, LLC
118-20
In Commercial Distribution

  • 00810050244725 ()

  • Height: 7 Inch
  • Width: 7 Inch
  • Length: 7 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
Guidewires
MICROVENTION INC.
GW0721006M
In Commercial Distribution

  • 00816777025494 ()

  • 0.014 inch x 210 cm
GW0721006M

  • Cardiac/peripheral vascular guidewire, single-use
Implant 4.1*7
DENTACK IMPLANTS LTD
EDI-4107
In Commercial Distribution

  • 07290112280497 ()


  • Screw endosteal dental implant, two-piece
Implant 3.75*7
DENTACK IMPLANTS LTD
EDI-3757
In Commercial Distribution

  • 07290112280480 ()


  • Screw endosteal dental implant, two-piece
Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyrogenic
PHARMACARIBE, LLC.
74060
In Commercial Distribution

  • 60850877007037 ()
  • 40850877007033 ()
  • 00850877007035 ()

  • Total Volume: 4 Milliliter
50190-740-60

  • Inhalation therapy saline solution, hypertonic
Kit Contains: CTF12, 5x100 Kii Fios ZTHR DP 10/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii Fios ADVFIX 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK325
In Commercial Distribution

  • 20607915132471 ()


  • Tissue extraction bag
  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
DrugSmart Cup 7, AMP500/COC150/MET500/MDMA/THC/OXY/OPI + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
60775D-6AB
In Commercial Distribution

  • 00812203030599 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel DrugSmart Dip, AMP500/COC150/THC50/BAR200/BZO200/MDMA500/MOR
CHEMTRON BIOTECH INC
30735D
In Commercial Distribution

  • 00812203030070 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Distal Access Catheter
Stryker Corporation
IC068132
In Commercial Distribution

  • 07613327417227 ()

  • Length: 132.0 Centimeter
  • Lumen/Inner Diameter: 0.068 Inch
IC068132

  • Vascular guide-catheter, single-use
Distal Access Catheter
Stryker Corporation
IC068125
In Commercial Distribution

  • 07613327417210 ()

  • Length: 125.0 Centimeter
  • Lumen/Inner Diameter: 0.068 Inch
IC068125

  • Vascular guide-catheter, single-use
Distal Access Catheter
Stryker Corporation
IC068115
In Commercial Distribution

  • 07613327417203 ()

  • Length: 115.0 Centimeter
  • Lumen/Inner Diameter: 0.068 Inch
IC068115

  • Vascular guide-catheter, single-use
No Description
OSADA ELECTRIC CO.,LTD.
AP set 7
In Commercial Distribution

  • 04580406860720 ()
50796

  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
No Description
BIOTRONIK SE & Co. KG
399443
Not in Commercial Distribution

  • 04035479136383 ()
399443

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
399441
Not in Commercial Distribution

  • 04035479136369 ()
399441

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
399431
Not in Commercial Distribution

  • 04035479136260 ()
399431

  • Dual-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
399429
Not in Commercial Distribution

  • 04035479136246 ()
399429

  • Dual-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
399427
Not in Commercial Distribution

  • 04035479136222 ()
399427

  • Cardiac resynchronization therapy implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
399425
Not in Commercial Distribution

  • 04035479136208 ()
399425

  • Cardiac resynchronization therapy implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
399423
Not in Commercial Distribution

  • 04035479136185 ()
399423

  • Cardiac resynchronization therapy implantable defibrillator
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