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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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Silicone Spheres (19 mm, 3.6 cc) In Bulk - M87211219V95

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-219V
Not in Commercial Distribution

  • M87211219V95 ()

  • Total Volume: 3.6 Milliliter
  • Outer Diameter: 19 Millimeter


  • Orbital sphere implant

Silicone Spheres (16 mm, 2.1 cc) In Bulk - M87211216V92

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-216V
Not in Commercial Distribution

  • M87211216V92 ()

  • Outer Diameter: 16 Millimeter
  • Total Volume: 2.1 Milliliter


  • Orbital sphere implant

Silicone Spheres (15 mm, 1.8 cc) In Bulk - M87211215V91

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-215V
Not in Commercial Distribution

  • M87211215V91 ()

  • Total Volume: 1.8 Milliliter
  • Outer Diameter: 15 Millimeter


  • Orbital sphere implant

Silicone Spheres (14 mm, 1.4 cc) In Bulk - M87211214V90

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-214V
Not in Commercial Distribution

  • M87211214V90 ()

  • Total Volume: 1.4 Milliliter
  • Outer Diameter: 14 Millimeter


  • Orbital sphere implant

SCOTT'S GUTTA PERCHA P-TAPER 100/bx CC # F3 - D77810391921

GUTTA PERCHA POINTS (100/box) Type: PT Taper, Size: F3; For more information: https://www.scottsdental.com/catalog/product/view/id/23535/s/tapered-gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9192
In Commercial Distribution

  • D77810391920 ()
  • D77810391921 ()
103-9192

  • Natural gutta-percha

SCOTT'S GUTTA PERCHA P-TAPER 100/bx CC # F2 - D77810391901

GUTTA PERCHA POINTS (100/box) Type: PT Taper, Size: F2; For more information: https://www.scottsdental.com/catalog/product/view/id/23535/s/tapered-gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9190
In Commercial Distribution

  • D77810391900 ()
  • D77810391901 ()
103-9190

  • Natural gutta-percha

SCOTT'S GUTTA PERCHA P-TAPER 100/bx CC # F1 - D77810391881

GUTTA PERCHA POINTS (100/box) Type: PT Taper, Size: F1; For more information: https://www.scottsdental.com/catalog/product/view/id/23535/s/tapered-gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9188
In Commercial Distribution

  • D77810391880 ()
  • D77810391881 ()
103-9188

  • Natural gutta-percha

SCOTT'S ABSORBENT PTS 200/bx CC # 45-80 ASST - D77810390911

ABSORBENT POINTS (200/box) Type: ISO, Size: 45-80 (Assorted); For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9091
In Commercial Distribution

  • D77810390910 ()
  • D77810390911 ()
103-9091

  • Endodontic paper point

SCOTT'S ABSORBENT PTS 200/bx CC # 15-40 ASST - D77810390891

ABSORBENT POINTS (200/box) Type: ISO, Size: 15-40 (Assorted); For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9089
In Commercial Distribution

  • D77810390890 ()
  • D77810390891 ()
103-9089

  • Endodontic paper point

SCOTT'S GUTTA PERCHA PTS 120/bx CC # 120 - D77810390331

GUTTA PERCHA POINTS (120/box) Size: 120; For more information: https://www.scottsdental.com/catalog/product/view/id/23534/s/gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9033
In Commercial Distribution

  • D77810390330 ()
  • D77810390331 ()
103-9033

  • Natural gutta-percha
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