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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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SensiLight - salmon - 05060445340029

The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL050US02SNS
In Commercial Distribution

  • 05060445340029 ()


  • Intense pulsed light skin surface treatment system

SensiLight - mint - 05060445340012

The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
EL GLOBAL TRADE LTD
IPL050US03SNS
In Commercial Distribution

  • 05060445340012 ()


  • Intense pulsed light skin surface treatment system

The Glider™ Dental Treatment Station - 00850309007770

Integrated delivery system with up to two handpiece connections, dual air/water syringes and titanium saliva ejector and high-volume evacuator. Delivery system features programmable electro-mechanically adjusted height to allow for sit down to stand up procedures and Wilsonart solid surface worktop and heavy duty 3” casters. Storage includes two side rails for accessory brackets, saline bag hooks, and sharps containers. Includes back rail with two storage tubs.
ASI MEDICAL, INC.
90-2148
Not in Commercial Distribution

  • 00850309007770 ()


  • Dental delivery system instrument unit, electric

Advanced Dental/ Endodontics Systems - Umbilical Cart - 00850309007763

Advanced Dental/ Endodontics Systems - Umbilical Cart
ASI MEDICAL, INC.
90-2143DS
In Commercial Distribution

  • 00850309007763 ()


  • Dental delivery system instrument unit, electric

Advanced Dental/ Endodontics Systems - Umbilical Cart - 00850309007497

Advanced Endodontic System - Classic Series Door
ASI MEDICAL, INC.
90-2143ES
In Commercial Distribution

  • 00850309007497 ()


  • Dental delivery system instrument unit, electric

Standard Triton Self-Contained Delivery Systems - 00850309007480

Triton Traveler
ASI MEDICAL, INC.
90-2625
In Commercial Distribution

  • 00850309007480 ()


  • Dental delivery system instrument unit, electric

Extended Worktop - Umbilical Carts - 00850309007473

No Description
ASI MEDICAL, INC.
90-2042
In Commercial Distribution

  • 00850309007473 ()


  • Dental delivery system instrument unit, electric

Extended Worktop - Umbilical Carts - 00850309007466

No Description
ASI MEDICAL, INC.
90-2044
In Commercial Distribution

  • 00850309007466 ()
90-2044

  • Dental delivery system instrument unit, electric

Extended Worktop - Self-Contained Carts - 00850309007459

No Description
ASI MEDICAL, INC.
90-2006
In Commercial Distribution

  • 00850309007459 ()
90-200

  • Dental delivery system instrument unit, electric

Extended Worktop - Umbilical Carts - 00850309007442

No Description
ASI MEDICAL, INC.
90-2044S
In Commercial Distribution

  • 00850309007442 ()
90-2044S

  • Dental delivery system instrument unit, electric

Extended Worktop - Self-Contained Carts - 00850309007435

No Description
ASI MEDICAL, INC.
90-2026S
In Commercial Distribution

  • 00850309007435 ()
90-2026S

  • Dental delivery system instrument unit, electric

Extended Worktop - Self-Contained Carts - 00850309007428

No Description
ASI MEDICAL, INC.
90-2006S
In Commercial Distribution

  • 00850309007428 ()
90-2006S

  • Dental delivery system instrument unit, electric

Extended Worktop - Umbilical Carts - 00850309007411

No Description
ASI MEDICAL, INC.
90-1044S
In Commercial Distribution

  • 00850309007411 ()
90-1044S

  • Dental delivery system instrument unit, electric

Trident Dental System - Extended Worktop - 00850309007381

Trident Dental System
ASI MEDICAL, INC.
90-2126
In Commercial Distribution

  • 00850309007381 ()
90-2126

  • Dental delivery system instrument unit, electric

Trident Dental System - Extended Worktop - 00850309007374

Trident Dental System
ASI MEDICAL, INC.
90-2026
In Commercial Distribution

  • 00850309007374 ()
90-2026

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007367

Advanced Endodontic System
ASI MEDICAL, INC.
90-2403E
In Commercial Distribution

  • 00850309007367 ()
90-2403E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007350

Advanced Dental System
ASI MEDICAL, INC.
90-2403D
In Commercial Distribution

  • 00850309007350 ()
90-2403D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007343

Advanced Endodontic System
ASI MEDICAL, INC.
90-2401E
In Commercial Distribution

  • 00850309007343 ()
90-2401E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007336

Advanced Dental System
ASI MEDICAL, INC.
90-2401D
In Commercial Distribution

  • 00850309007336 ()
90-2401D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007329

Advanced Endodontic System
ASI MEDICAL, INC.
90-2250E
In Commercial Distribution

  • 00850309007329 ()
90-2250E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007312

Advanced Dental System
ASI MEDICAL, INC.
90-2250D
In Commercial Distribution

  • 00850309007312 ()
90-2250D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007305

Advanced Endodontic System
ASI MEDICAL, INC.
90-2134E/C
In Commercial Distribution

  • 00850309007305 ()
90-2134E/C

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007299

Advanced Dental System
ASI MEDICAL, INC.
90-2134D/C
In Commercial Distribution

  • 00850309007299 ()
90-2134D/C

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007282

Advanced Endodontic System
ASI MEDICAL, INC.
90-2134E
In Commercial Distribution

  • 00850309007282 ()
90-2134E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007275

Advanced Dental System
ASI MEDICAL, INC.
90-2134D
In Commercial Distribution

  • 00850309007275 ()
90-2134D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007268

Advanced Endodontic System
ASI MEDICAL, INC.
90-2133E
In Commercial Distribution

  • 00850309007268 ()
90-2133E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007251

Advanced Dental System
ASI MEDICAL, INC.
90-2133D
In Commercial Distribution

  • 00850309007251 ()
90-2133D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007244

Advanced Endodontic System
ASI MEDICAL, INC.
90-2143E
In Commercial Distribution

  • 00850309007244 ()
90-2143E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007237

Advanced Dental System
ASI MEDICAL, INC.
90-2143D
In Commercial Distribution

  • 00850309007237 ()
90-2143D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007220

Advanced Endodontic System
ASI MEDICAL, INC.
90-2140E
In Commercial Distribution

  • 00850309007220 ()
90-2140E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007213

Advanced Dental System
ASI MEDICAL, INC.
90-2140D
In Commercial Distribution

  • 00850309007213 ()
90-2140D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007206

Advanced Endodontic System
ASI MEDICAL, INC.
90-2255E
In Commercial Distribution

  • 00850309007206 ()
90-2255E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007190

Advanced Dental System
ASI MEDICAL, INC.
90-2255D
In Commercial Distribution

  • 00850309007190 ()
90-2255D

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007176

Advanced Dental System
ASI MEDICAL, INC.
90-2125D
In Commercial Distribution

  • 00850309007176 ()
90-2125D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007169

Advanced Endodontic System
ASI MEDICAL, INC.
90-2115E
In Commercial Distribution

  • 00850309007169 ()
90-2115E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007152

Advanced Dental System
ASI MEDICAL, INC.
90-2115D
In Commercial Distribution

  • 00850309007152 ()
90-2115D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007145

Advanced Endodontic System
ASI MEDICAL, INC.
90-2110E
In Commercial Distribution

  • 00850309007145 ()
90-2110E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007138

Advanced Dental System
ASI MEDICAL, INC.
90-2110D
In Commercial Distribution

  • 00850309007138 ()
90-2110D

  • Dental delivery system instrument unit, electric

Triton - 00850309007121

Triton Dental System
ASI MEDICAL, INC.
90-2025M
In Commercial Distribution

  • 00850309007121 ()
90-2025M

  • Dental delivery system instrument unit, electric

Triton - 00850309007114

Triton Dental System
ASI MEDICAL, INC.
90-2025
In Commercial Distribution

  • 00850309007114 ()
90-2025

  • Dental delivery system instrument unit, electric
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