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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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Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems. Immediate loading should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone.
STERNGOLD DENTAL LLC
901585
In Commercial Distribution

  • 00841549108549 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems. Immediate loading should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone.
STERNGOLD DENTAL LLC
901584
Not in Commercial Distribution

  • 00841549108532 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems. Immediate loading should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone.
STERNGOLD DENTAL LLC
901583
Not in Commercial Distribution

  • 00841549108525 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems. Immediate loading should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone.
STERNGOLD DENTAL LLC
901582
Not in Commercial Distribution

  • 00841549108518 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems. Immediate loading should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone.
STERNGOLD DENTAL LLC
901581
Not in Commercial Distribution

  • 00841549108501 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments.For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems. Immediate loading should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone.
STERNGOLD DENTAL LLC
901580
Not in Commercial Distribution

  • 00841549108495 ()


  • Dental implant suprastructure, permanent, preformed
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant mis-angulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization. This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901451
Not in Commercial Distribution

  • 00841549107986 ()


  • Dental implant suprastructure, permanent, preformed
Sil-Select Plus™ Sperm preparation media Sil-Select Plus™ is our home made new and improved gradient system for semen preparation. Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Extensive testing during the design of the product has shown it to be non-cytotoxic and non-irritant with a non-significant allergenic potential. Sil-Select Plus™ is produced from raw colloidal silica, so we have full control over each step in the production process. We have developed a very accurate purification system which results in a very clean product with endotoxin levels below 0.25EU/ml (typically below 0.1EU/ml). We now also offer Sil-Select Plus in an 80% dilution for use in IVF procedures. Sil-Select Plus has a 18 month shelf life from date of produce. Sil-Select Plus™ is CE marked as a medical device according to the Medical Device Directive 93/42/EEC. For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website: http://fertipro.com/index.php?page=media&sub=sip
Fertipro NV
SIP100LO_AF (100ml)
Not in Commercial Distribution

  • 54119670011634 ()


  • IVF medium
Sil-Select Plus™ Sperm preparation media Sil-Select Plus™ is our home made new and improved gradient system for semen preparation. Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Extensive testing during the design of the product has shown it to be non-cytotoxic and non-irritant with a non-significant allergenic potential. Sil-Select Plus™ is produced from raw colloidal silica, so we have full control over each step in the production process. We have developed a very accurate purification system which results in a very clean product with endotoxin levels below 0.25EU/ml (typically below 0.1EU/ml). We now also offer Sil-Select Plus in an 80% dilution for use in IVF procedures. Sil-Select Plus has a 18 month shelf life from date of produce. Sil-Select Plus™ is CE marked as a medical device according to the Medical Device Directive 93/42/EEC. For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website: http://fertipro.com/index.php?page=media&sub=sip
Fertipro NV
SIP020LO_AF (20ml)
Not in Commercial Distribution

  • 54119670010262 ()


  • IVF medium
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 3 gallon four pack sharps disposal ship back system (Includes four 3 gallon sharps container, box, bag, zip tie).
PUREWAY COMPLIANCE
12
In Commercial Distribution

  • 10853022008090 ()
  • 00853022008086 ()

  • Total Volume: 3.0 Gallon
40043

  • Sharps container
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