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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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Clearsplint Disc 95mm x 20mm Clover Edge Magenta BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2095ZBESM1
In Commercial Distribution

  • D810PCSD2095ZBESM111 ()
PCSD2095ZBESM1

  • Mouthguard, single-use
Clearsplint Disc 95mm x 20mm Clover Edge Blue BES 1 Unit
ASTRON DENTAL CORPORATION
PCSD2095ZBESB1
In Commercial Distribution

  • D810PCSD2095ZBESB111 ()
PCSD2095ZBESB1

  • Mouthguard, single-use
Package of 1 disc 95mmX20mm Zirkonzahn/Clover Leaf Edge
ASTRON DENTAL CORPORATION
PCSD95
In Commercial Distribution

  • D810PCSD2095Z111 ()
PCSD95

  • Mouthguard, single-use
Package of 1 disc 98mmX16mm with shoulder
ASTRON DENTAL CORPORATION
PCSD16
In Commercial Distribution

  • D810PCSD1698111 ()
PCSD16

  • Mouthguard, single-use
Clearsplint Disc 95mm x 16mm Clover Edge Clear 1 Unit
ASTRON DENTAL CORPORATION
PCSD1695Z1
In Commercial Distribution

  • D810PCSD1695Z111 ()
PCSD1695Z1

  • Mouthguard, single-use
Event Marker Switch, RigiScan
GOTOP MEDICAL INC
9026
In Commercial Distribution

  • 00854759007106 ()
9026

  • Penile tumescence ambulatory recorder
Flash Drive Assembly
GOTOP MEDICAL INC
9034
In Commercial Distribution

  • 00854759007090 ()
9034

  • Penile tumescence ambulatory recorder
Communication Cable
GOTOP MEDICAL INC
606003-004
In Commercial Distribution

  • 00854759007083 ()
606003-004

  • Penile tumescence ambulatory recorder
RigiScan Monitor
GOTOP MEDICAL INC
9003
In Commercial Distribution

  • 00854759007014 ()
9003

  • Penile tumescence ambulatory recorder
RigiScan Plus System
GOTOP MEDICAL INC
9001
In Commercial Distribution

  • 00854759007007 ()
9001

  • Penile tumescence ambulatory recorder
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