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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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VISUMAX - 04049471095111

The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in the treatment objective . The optical system focuses the laser beam into the corneal tissue. The VISUMAX Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism • for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters, • for cylinder from -0.75 diopters through -3.00 diopters, • when refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude.
Carl Zeiss Meditec AG
VISUMAX 800 or 09511
In Commercial Distribution

  • 04049471095111 ()

  • Weight: 520 Kilogram
  • LxW 1.71m x0.925


  • Femtosecond ophthalmic solid-state laser system

Eversense E3 Adhesive Patches Kit, 180-pack - 00817491022882

Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin. The kit contains five 30-packs of white patches and one 30-pack of clear patches.
SENSEONICS, INCORPORATED
FG-6500-01-300
In Commercial Distribution

  • 00817491022882 ()
FG-6500-01-300

  • Implantable glucose monitoring system

RHA® 4 - 07640173234388

"One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173234371) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2
In Commercial Distribution

  • 07640173234388 ()
940083/03

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 3 - 07640173234241

"One box of RHA® 3 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173234159) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 3 US 1ml Schott/2 aig. TSK 27G1/2
In Commercial Distribution

  • 07640173234241 ()
940008/03

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 2 - 07640173234234

"One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173234227) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 2 US 1ml Schott/2 aig. TSK 30G1/2
In Commercial Distribution

  • 07640173234234 ()
940007/03

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 4 - 07640173234210

"One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a 1,2mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173234203) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 4 US 1.2ml Schott/2 aig. TSK 27G1/2
Not in Commercial Distribution

  • 07640173234210 ()
  • 07640173234203 ()
940083/02

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® Redensity - 07640173234197

"One box of RHA® Redensity contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173234180) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2
In Commercial Distribution

  • 07640173234197 ()
940056/02

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 3 - 07640173234173

"One box of RHA® 3 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173234166) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 3 US 1ml Schott/2 aig. TSK 27G1/2
In Commercial Distribution

  • 07640173234166 ()
  • 07640173234173 ()
940008/04

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® 2 - 07640173234128

"One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173234111) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 2 - Terumo - US
In Commercial Distribution

  • 07640173234111 ()
  • 07640173234128 ()
940103

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

RHA® Redensity - 07640173233763

"One box of RHA® Redensity contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173233794) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/2
In Commercial Distribution

  • 07640173233763 ()
  • 07640173233794 ()
940056/01

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
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