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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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Tasso-M20 - 00860006434540

The Tasso-M20 is used to collect, store, and transport capillary blood for testing in a centralized laboratory. It is to be used in non-clinical settings for use in adult populations.
Tasso Inc.
K1001-02
In Commercial Distribution

  • 00860006434540 ()


  • Capillary blood collection system IVD

SUUCARE - 06938444982245

This product is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 3 midstreams in one box.
Equinox Biotech Co., Ltd.
82245
Not in Commercial Distribution

  • 06938444982245 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

ARC InstaTemp Infrared Thermometer - 00853524006009

InstaTemp Digital Non-Touch Infrared Thermometer is intended to be used to measure temperature in infants and adults. The InstaTemp can be used in the home or in the clinical setting.
ARC DEVICES USA INC
600
In Commercial Distribution

  • 00853524006009 ()


  • Infrared patient thermometer, skin

si_Mochi - 05060548020033

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
MIS1210
In Commercial Distribution

  • 05060548020033 ()


  • Bone matrix implant, synthetic, non-antimicrobial

si_Mochi - 05060548020026

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
MIS1205
In Commercial Distribution

  • 05060548020026 ()


  • Bone matrix implant, synthetic, non-antimicrobial

System 2 BA - 05060548020552

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

System 2 BA - 05060548020545

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

Apex ASG - 05060548020484

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

Apex ASG - 05060548020477

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

BioViveSBG - 05060548020415

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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