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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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"One box of RHA® 3 Mepi contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173233398) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 3 Mepi - TSK - US
In Commercial Distribution

  • 07640173233398 ()
  • 07640173233473 ()
940031

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Neck Trial, Size 24, Lateral, Dual Taper
NEXTSTEP ARTHROPEDIX, LLC
10-81-0424
In Commercial Distribution

  • 00816127028281 ()


  • Femoral stem prosthesis trial
Neck Trial, Size 22, Lateral, Dual Taper
NEXTSTEP ARTHROPEDIX, LLC
10-81-0422
In Commercial Distribution

  • 00816127028274 ()


  • Femoral stem prosthesis trial
No Description
BIOTRONIK SE & Co. KG
3.50
In Commercial Distribution

  • 07640130457300 ()
459761

  • Implantable cardiac device management application software
Straumann Emdogain Multipack, Straumann Emdogain 3 x 0.7 ml (30 mg/ml), Straumann PrefGel 3 x 0.6 ml (24% EDTA)
Institut Straumann AG
Emdogain
In Commercial Distribution

  • 07630031730022 ()
  • 07630031747013 ()

  • Total Volume: 2.1 Milliliter
  • Total Volume: 1.8 Milliliter
075.116W

  • Periodontal root surface regeneration material
Straumann Emdogain Multipack, Straumann Emdogain 3 x 0.3 ml (30 mg/ml), Straumann PrefGel 3 x 0.6 ml (24% EDTA)
Institut Straumann AG
Emdogain
In Commercial Distribution

  • 07630031730015 ()
  • 07630031747006 ()

  • Total Volume: 0.9 Milliliter
  • Total Volume: 1.8 Milliliter
075.114W

  • Periodontal root surface regeneration material
Straumann Emdogain, 5 x 0.15 ml (30 mg/ml)
Institut Straumann AG
Emdogain
In Commercial Distribution

  • 07630031729989 ()
  • 07630031746993 ()

  • Total Volume: 0.75 Milliliter
075.098W

  • Periodontal root surface regeneration material
Straumann Emdogain MI 0.3ml
Institut Straumann AG
Emdogain
In Commercial Distribution

  • 07630031747389 ()

  • Total Volume: 0.3 Milliliter
  • Total Volume: 0.6 Milliliter
075.133

  • Periodontal root surface regeneration material
Straumann Emdogain MI 0.15ml
Institut Straumann AG
Emdogain
In Commercial Distribution

  • 07630031747372 ()

  • Total Volume: 0.6 Milliliter
  • Total Volume: 0.15 Milliliter
075.132

  • Periodontal root surface regeneration material
Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consisting of four zones: The central spherical or aspheric zone, an annular “Reverse Zone(s)”surrounding the central zone with a curvature steeper (shorter radius) than the central zone, an “Alignment Zone(s)” generally paralleling the underlying corneal surface and peripheral curve(s) with a radius selected to create “edge lift” to promote tear flow under the lens and avoid impingement of the peripheral curve on the cornea. The lens design also includes a “rounded” edge terminus extending from the anterior to the posterior surfaces to promote comfort. Paragon RG-4 Contact Lenses for Corneal Reshaping are to be worn overnight with removal during all or part of each following day. The material is a thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for corneal reshaping are available as lathe cut firm contact lenses with blue, green, red and yellow tints containing D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon RG-4
In Commercial Distribution

  • B22220 ()


  • Orthokeratology contact lens
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