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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Essence Air Spa bathing system.
APOLLO CORP.
AS7102
In Commercial Distribution

  • 00866595000234 ()


  • Hydrotherapy bath/tank
Advantage Air Spa bathing system.
APOLLO CORP.
AS6300
In Commercial Distribution

  • 00866595000227 ()


  • Hydrotherapy bath/tank
Essence Whirlpool bathing system.
APOLLO CORP.
ES7100
In Commercial Distribution

  • 00866595000210 ()


  • Hydrotherapy bath/tank
Advantage Whirlpool bathing system.
APOLLO CORP.
WP6300
In Commercial Distribution

  • 00866595000203 ()


  • Hydrotherapy bath/tank
Immersion hydrobath.
GRIMM SCIENTIFIC INDUSTRIES INC
CRYOTherm
In Commercial Distribution

  • 00861047000305 ()


  • Hydrotherapy bath/tank
Iliac screw 8.5x50mm 25 deg
INGENIUMSPINE, LLC
55258550
In Commercial Distribution

  • 00843672100827 ()


  • Gravity-convection laboratory oven
220-240V 50/60 Hz
SHANDON DIAGNOSTICS LIMITED
Histostar
Not in Commercial Distribution

  • 00505166300228 ()


  • Tissue embedding unit IVD
Iliac screw 8.5x80mm 25 deg
INGENIUMSPINE, LLC
55258580
In Commercial Distribution

  • 00843672100858 ()


  • Gravity-convection laboratory oven
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Switch
In Commercial Distribution

  • 05051663518314 ()
AP16629

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Cable
In Commercial Distribution

  • 05051663518307 ()
AP16125

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Waste Area Cover
In Commercial Distribution

  • 05051663518246 ()
A81030307

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Dispense Nozzle Short
In Commercial Distribution

  • 05051663518239 ()
A81030197

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Document Holder Kit
In Commercial Distribution

  • 05051663518222 ()
A81010036

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Electric Forceps Blue
In Commercial Distribution

  • 05051663518215 ()
A81010035

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Electric Forceps Yellow
In Commercial Distribution

  • 05051663518208 ()
A81010034

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Electric Forceps Red
In Commercial Distribution

  • 05051663518192 ()
A81010033

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Magnifier Assembly
In Commercial Distribution

  • 05051663518185 ()
A81010032

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Wax Scraper Kit
In Commercial Distribution

  • 05051663518178 ()
A81010031

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Tamping Tool Kit
In Commercial Distribution

  • 05051663518161 ()
A81010030

  • Tissue embedding unit IVD
No Description
SHANDON DIAGNOSTICS LIMITED
EMBEDDING MODULE
In Commercial Distribution

  • 05051663009683 ()


  • Tissue embedding unit IVD
No Description
SHANDON DIAGNOSTICS LIMITED
EMBEDDING MODULE
In Commercial Distribution

  • 05051663009676 ()


  • Tissue embedding unit IVD
No Description
SHANDON DIAGNOSTICS LIMITED
COLD MODULE
In Commercial Distribution

  • 05051663009669 ()


  • Tissue embedding unit IVD
No Description
SHANDON DIAGNOSTICS LIMITED
COLD MODULE
In Commercial Distribution

  • 05051663009652 ()


  • Tissue embedding unit IVD
No Description
SHANDON DIAGNOSTICS LIMITED
COLD MODULE
In Commercial Distribution

  • 05051663009645 ()


  • Tissue embedding unit IVD
No Description
SHANDON DIAGNOSTICS LIMITED
HISTOSTAR
In Commercial Distribution

  • 05051663009638 ()


  • Tissue embedding unit IVD
No Description
SHANDON DIAGNOSTICS LIMITED
HISTOSTAR
In Commercial Distribution

  • 05051663009621 ()


  • Tissue embedding unit IVD
No Description
SHANDON DIAGNOSTICS LIMITED
HISTOSTAR
In Commercial Distribution

  • 05051663009614 ()


  • Tissue embedding unit IVD
50/60HZ EX-DEMO
SHANDON DIAGNOSTICS LIMITED
HISTOSTAR 100-120V
In Commercial Distribution

  • 05051663009249 ()


  • Tissue embedding unit IVD
EX-DEMO 220-240V 50/60HZ
SHANDON DIAGNOSTICS LIMITED
Histostar Cold Module
In Commercial Distribution

  • 05051663003117 ()


  • Tissue embedding unit IVD
220-240V 50/60 HZ
SHANDON DIAGNOSTICS LIMITED
Histostar Ex-Demo
In Commercial Distribution

  • 05051663003100 ()


  • Tissue embedding unit IVD
220-240V 50/60HZ (CHINA ONLY)
SHANDON DIAGNOSTICS LIMITED
EMBEDDING MODULE
In Commercial Distribution

  • 05051663002578 ()


  • Tissue embedding unit IVD
No Description
SHANDON DIAGNOSTICS LIMITED
EMBEDDING MODULE
In Commercial Distribution

  • 05051663002561 ()


  • Tissue embedding unit IVD
220-240V 50/60HZ (CHINA ONLY)
SHANDON DIAGNOSTICS LIMITED
Cold Module
In Commercial Distribution

  • 05051663002431 ()


  • Tissue embedding unit IVD
100-120V 50/60HZ
SHANDON DIAGNOSTICS LIMITED
COLD MODULE
In Commercial Distribution

  • 05051663002424 ()


  • Tissue embedding unit IVD
220-240V 50/60HZ
SHANDON DIAGNOSTICS LIMITED
Cold Module
In Commercial Distribution

  • 05051663002417 ()


  • Tissue embedding unit IVD
220-240V 50/60 Hz (CHINA ONLY)
SHANDON DIAGNOSTICS LIMITED
Histostar
In Commercial Distribution

  • 05051663002301 ()


  • Tissue embedding unit IVD
100-120V 50/60 Hz
SHANDON DIAGNOSTICS LIMITED
Histostar
In Commercial Distribution

  • 05051663002295 ()


  • Tissue embedding unit IVD
No Description
SHANDON DIAGNOSTICS LIMITED
HISTOSTAR
In Commercial Distribution

  • 05051663002288 ()


  • Tissue embedding unit IVD
Cryo Module (Requires connnection to product code 5108 for operation)
SAKURA FINETEK U.S.A., INC.
5109
In Commercial Distribution

  • 04946433600515 ()
5109

  • Tissue embedding unit IVD
Embedding Module
SAKURA FINETEK U.S.A., INC.
5108
In Commercial Distribution

  • 04946433600508 ()
5108

  • Tissue embedding unit IVD
Plus Cryo Console
SAKURA FINETEK U.S.A., INC.
5250
In Commercial Distribution

  • 04946433600492 ()
5250

  • Tissue embedding unit IVD
Automated Embedder
SAKURA FINETEK U.S.A., INC.
7090
In Commercial Distribution

  • 04946433600362 ()
7090

  • Tissue embedding unit IVD
FLUIDTHERAPY DOUBLE EXTREMITY
DJO, LLC
FLU115D
In Commercial Distribution

  • 00190446305149 ()


  • Hydrotherapy bath/tank
FLUIDOTHERAPY FT110 SINGLE
DJO, LLC
FLU110D
In Commercial Distribution

  • 00190446305132 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/1000 (120V)
In Commercial Distribution

  • 08436602170261 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/1000
In Commercial Distribution

  • 08436602170254 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/400 (120V)
In Commercial Distribution

  • 08436602170247 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/400
In Commercial Distribution

  • 08436602170230 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/340 (120V)
In Commercial Distribution

  • 08436602170223 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/340
In Commercial Distribution

  • 08436602170216 ()


  • Hydrotherapy bath/tank
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