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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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AMSafe® 7 in. (18cm) Microbore Bifurcated Ext. Set w/2 MicroClave, 3 clamps, Rotating Male luer Approx. Priming Volume 1.3 mL
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411005668 ()
  • 10704411005667 ()
MB4BR07

  • Intravenous administration tubing extension set
No Description
Humeca B.V.
5.BLHUL/1
In Commercial Distribution

  • 08717903490273 ()
  • 08717903490242 ()
5.BLHUL/1

  • Dermatome blade, single-use
No Description
Biomet Orthopedics, LLC
8145-03-101
In Commercial Distribution

  • 00887868038839 ()
814503101

  • Bone nail end-cap
No Description
Lonza Verviers
BE26-279P20/2
In Commercial Distribution

  • 05407010127195 ()
BE26-279P20/2

  • Differential/selective broth culture medium IVD
Human Serum Albumin (HSA)100mg/mL in Normal Saline. Not for Injection.
IRVINE SCIENTIFIC, LLC
9988-12x5ML
In Commercial Distribution

  • 00810195240187 ()
9988

  • IVF medium
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10cc suspended in a biocompatible hydrogel solution packed in two long cartridges ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch are sealed in an outer Tyvek pouch and then packed in a carton box.
BIOSTONE CO. LIMITED
SYS210M
In Commercial Distribution

  • 05060548020552 ()
SYS210M

  • Bone matrix implant, synthetic, non-antimicrobial
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 5cc suspended in a biocompatible hydrogel solution packed in one long cartridge ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch sealed in an outer Tyvek pouch. Then packed in a carton box.
BIOSTONE CO. LIMITED
SYS205M
In Commercial Distribution

  • 05060548020545 ()
SYS205M

  • Bone matrix implant, synthetic, non-antimicrobial
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10cc suspended in a biocompatible hydrogel solution packed in two long cartridges ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch are sealed in an outer Tyvek pouch and then packed in a carton box.
BIOSTONE CO. LIMITED
966-1210
In Commercial Distribution

  • 05060548020484 ()
966-1210

  • Bone matrix implant, synthetic, non-antimicrobial
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 5cc suspended in a biocompatible hydrogel solution packed in one long cartridge ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch sealed in an outer Tyvek pouch. Then packed in a carton box.
BIOSTONE CO. LIMITED
966-1205
In Commercial Distribution

  • 05060548020477 ()
966-1205

  • Bone matrix implant, synthetic, non-antimicrobial
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10cc suspended in a biocompatible hydrogel solution packed in two long cartridges ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch are sealed in an outer Tyvek pouch and then packed in a carton box.
BIOSTONE CO. LIMITED
1DE-MIS-10
In Commercial Distribution

  • 05060548020415 ()
1DE-MIS-10

  • Bone matrix implant, synthetic, non-antimicrobial
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