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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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Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lower Baseplate Resin (905012), one 12-pack Eclipse Resilient Resin (906080), one 12-pack Eclipse Original Upper Baseplate Resin (905001), one 12-pack Eclipse Original Lower Baseplate Resin (905007), one Eclipse Wax Remover (905620), one PermaSoft Soft Denture Liner Kit (N811100), and one Eclipse Bonding Agent Kit (905550), along with miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Package with Bonding Agent
Not in Commercial Distribution

  • D0019056450 ()
905645

  • Dental appliance fabrication material, resin
Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lower Baseplate Resin (905012), one 12-pack Eclipse Resilient Resin (906080), one 12-pack Eclipse Original Upper Baseplate Resin (905001), one 12-pack Eclipse Original Lower Baseplate Resin (905007), one Eclipse Wax Remover (905620), and one PermaSoft Soft Denture Liner Kit (N811100), along with miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Package
Not in Commercial Distribution

  • D0019055850 ()
905585

  • Dental appliance fabrication material, resin
Thigh Calibrated V-Lok Cuff & Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1884MFCC
In Commercial Distribution

  • 00810010922595 ()
1884MFCC

  • Aneroid manual sphygmomanometer
Infant Calibrated V-Lok Cuff & Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1882MFCC
In Commercial Distribution

  • 00810010922557 ()
1882MFCC

  • Aneroid manual sphygmomanometer
Child Calibrated V-Lok Cuff & Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1881MFCC
In Commercial Distribution

  • 00810010922526 ()
1881MFCC

  • Aneroid manual sphygmomanometer
Adult Calibrated V-Lok Cuff & Latex Inflation Bag with One Male & One Female Colder Connectors
W. A. BAUM CO., INC.
1880MFCC
In Commercial Distribution

  • 00810010922502 ()
1880MFCC

  • Aneroid manual sphygmomanometer
LacriCATH DCP315-UNIT contains one lacrimal duct catheter (3mm), and one AQL 1015 Inflation device.
QUEST MEDICAL INC
DCP315-UNIT
In Commercial Distribution

  • 20634624438310 ()


  • Lacrimal intubation set
LacriCATH DCP2mm Unilateral kit. Contains one Lacrimal Duct Catheter and one AQL1015 Inflation device.
QUEST MEDICAL INC
DCP213-UNIT
In Commercial Distribution

  • 20634624438211 ()


  • Lacrimal intubation set
OBALON® Balloon System - contains one Obalon Balloon Kit and one Obalon Accessory Kit
Reshape Lifesciences Inc.
9500-0001
Not in Commercial Distribution

  • 10859810006057 ()
  • 00859810006050 ()


  • Appetite-suppression gastric balloon
Green Polyglycolic Acid Braid Size 2-0 one C-2 needle & one CST-43 needle 36" BSC
TELEFLEX INCORPORATED
IPN056768
In Commercial Distribution

  • 04026704735334 ()
  • 14026704735331 ()

  • Suture Length 36", Needle 1 Length 0.160", Needle 2 Length 1.030"
833-244

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
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