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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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The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901344
In Commercial Distribution

  • 00841549107290 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901343
In Commercial Distribution

  • 00841549107283 ()


  • Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901342
In Commercial Distribution

  • 00841549107276 ()


  • Screw endosteal dental implant, two-piece
Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0442
In Commercial Distribution

  • 00885672103392 ()

  • Flow Rate: JR: 32 mL/sec, JL: 29 mL/sec, PT: 33 mL/sec
  • Recommended Pressure Limit: 1200 psi max.
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • JL 4.0/120 cm, JR 4.0/120 cm, Pigtail 145°/120 cm
  • Pigtail Side Holes: 5
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
ANG4-0442

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0240
In Commercial Distribution

  • 00885672101916 ()

  • Recommended Pressure Limit: 1200 psi max.
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • JL 4.0/110 cm, JR 4.0/110 cm, Pigtail 145°/120 cm
  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Pigtail Side Holes: 5
  • Flow Rate: JR: 28 mL/sec, JL: 28 mL/sec, PT: 29 mL/sec
ANG4-0240

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0239
In Commercial Distribution

  • 00885672101909 ()

  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Recommended Pressure Limit: 1200 psi max.
  • JL 4.0/110 cm, JR 4.0/110 cm, Straight Pigtail/120 cm
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Flow Rate: JR: 28 mL/sec, JL: 28 mL/sec, PT: 30 mL/sec
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Pigtail Side Holes: 5
  • Maximum Recommended Guidewire 0.038 in
ANG4-0239

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0040
In Commercial Distribution

  • 00885672101893 ()

  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 28 mL/sec, JL: 29 mL/sec, PT: 29 mL/sec
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Pigtail Side Holes: 5
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Recommended Pressure Limit: 1200 psi max.
  • Maximum Recommended Guidewire 0.038 in
  • JL 4.0/100 cm, JR 4.0/100 cm, Pigtail 145°/110 cm
ANG4-0040

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0039
In Commercial Distribution

  • 00885672101886 ()

  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 28 mL/sec, JL: 29 mL/sec, PT: 31 mL/sec
  • JL 4.0/100 cm, JR 4.0/100 cm, Straight Pigtail/110 cm
  • Pigtail Side Holes: 5
  • Recommended Pressure Limit: 1200 psi max.
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
ANG4-0039

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 4F
Oscor Inc.
ANG4-0238
Not in Commercial Distribution

  • 00885672101879 ()

  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
  • Recommended Pressure Limit: 1200 psi max.
  • JL 4.0/110 cm, JR 4.0/110 cm, Pigtail 145°/120 cm
  • Adelante Sigma Introducer, 4F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 18 mL/sec, JL: 18 mL/sec, PT: 18 mL/sec
  • Pigtail Side Holes: 5
  • Guidewire - Length: 150 cm, OD: 0.035 in
ANG4-0238

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 4F
Oscor Inc.
ANG4-0237
Not in Commercial Distribution

  • 00885672101862 ()

  • Flow Rate: JR: 18 mL/sec, JL: 18 mL/sec, PT: 19 mL/sec
  • Adelante Sigma Introducer, 4F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • JL 4.0/110 cm, JR 4.0/110 cm, Straight Pigtail/120 cm
  • Pigtail Side Holes: 5
  • Recommended Pressure Limit: 1200 psi max.
ANG4-0237

  • Angiographic catheter, single-use
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