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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For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117010014 ()
T1-72

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
BIOMET SPINE LLC
8734-0025
In Commercial Distribution

  • 00888480667544 ()

  • DILATOR ONE LATERAL
8734-0025

  • Orthopaedic surgical procedure kit, non-medicated, reusable
One Oasis Lubricant
GLOBAL PROTECTION CORP.
11L400C-2
In Commercial Distribution

  • 80726893120095 ()
  • 20726893120093 ()


  • Sexual lubricant
ONE Backdoor 3-Pack, Case of 36 (made @ GPC) (6 Bundles of 6).
GLOBAL PROTECTION CORP.
11010B3C-A / 11010B3C
In Commercial Distribution

  • 10726893114439 ()
  • 20726893114436 ()
  • 80726893114438 ()


  • Basic male condom, Hevea-latex
ONE Legend Latex Condom
LUNAMAX LLC
GS132B
In Commercial Distribution

  • 00850002174359 ()


  • Basic male condom, Hevea-latex
ONE Legend Latex Condom
LUNAMAX LLC
GS132
In Commercial Distribution

  • 00850002174342 ()


  • Basic male condom, Hevea-latex
ONE Vanish Latex Condom
LUNAMAX LLC
GS130B
In Commercial Distribution

  • 00850002174250 ()


  • Basic male condom, Hevea-latex
ONE Zero Thin Latex Condom
LUNAMAX LLC
GS134B
In Commercial Distribution

  • 00850002174243 ()


  • Basic male condom, Hevea-latex
ONE Zero Thin Latex Condom
LUNAMAX LLC
GS134
In Commercial Distribution

  • 00850002174236 ()


  • Basic male condom, Hevea-latex
ONE Vanish Latex Condom
LUNAMAX LLC
GS130
In Commercial Distribution

  • 00850002174120 ()


  • Basic male condom, Hevea-latex
ONE Pleasure Plus Latex Condoms
LUNAMAX LLC
GS138B
In Commercial Distribution

  • 00850002174786 ()


  • Basic male condom, Hevea-latex
ONE Chocolate Mint Flavored Latex Condom
LUNAMAX LLC
GS147
In Commercial Distribution

  • 00850002174762 ()


  • Basic male condom, Hevea-latex
ONE Banana Split Flavored Latex Condom
LUNAMAX LLC
GS146
In Commercial Distribution

  • 00850002174755 ()


  • Basic male condom, Hevea-latex
ONE Fresh Mint Flavored Latex Condom
LUNAMAX LLC
GS145
In Commercial Distribution

  • 00850002174748 ()


  • Basic male condom, Hevea-latex
ONE Chocolate Strawberry Flavored Latex Condom
LUNAMAX LLC
GS144
In Commercial Distribution

  • 00850002174731 ()


  • Basic male condom, Hevea-latex
ONE Island Punch Flavored Latex Condom
LUNAMAX LLC
GS143
In Commercial Distribution

  • 00850002174724 ()


  • Basic male condom, Hevea-latex
ONE Bubblegum Flavored Latex Condom
LUNAMAX LLC
GS142
In Commercial Distribution

  • 00850002174717 ()


  • Basic male condom, Hevea-latex
ONE Super Sensitive Latex Condom
LUNAMAX LLC
GS131
In Commercial Distribution

  • 00850002174663 ()


  • Basic male condom, Hevea-latex
ONE Color Sensations Latex Condom
LUNAMAX LLC
GS141
In Commercial Distribution

  • 00850002174656 ()


  • Basic male condom, Hevea-latex
ONE Glowing Pleasures Latex Condom
LUNAMAX LLC
GS137
In Commercial Distribution

  • 00850002174649 ()


  • Basic male condom, Hevea-latex
ONE Flavor Waves Flavored Latex Condom
LUNAMAX LLC
GS255
In Commercial Distribution

  • 00850002174427 ()


  • Basic male condom, Hevea-latex
ONE Super Studs Latex Condoms
LUNAMAX LLC
GS136
In Commercial Distribution

  • 00850002174410 ()


  • Basic male condom, Hevea-latex
ONE Pleasure Dome Latex Condom
LUNAMAX LLC
GS131
In Commercial Distribution

  • 00850002174373 ()


  • Basic male condom, Hevea-latex
ONE Tattoo Touch Latex Condom
LUNAMAX LLC
GS133
In Commercial Distribution

  • 00850002174366 ()


  • Basic male condom, Hevea-latex
One TT System, LimbLogic Distal, Extra Large Liner, Extra Large Sleeve
Willowwood Global LLC
ONE-TTVD-XL-XL
In Commercial Distribution

  • 00194711301461 ()
ONE-TTVD-XL-XL

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TT System, LimbLogic Distal, Medium Plus Liner, Small Sleeve
Willowwood Global LLC
ONE-TTVD-MP-SM
In Commercial Distribution

  • 00194711301454 ()
ONE-TTVD-MP-SM

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TT System, LimbLogic Distal, Medium Plus Liner, Medium Sleeve
Willowwood Global LLC
ONE-TTVD-MP-MD
In Commercial Distribution

  • 00194711301447 ()
ONE-TTVD-MP-MD

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TT System, LimbLogic Distal, Medium Plus Liner, Large Sleeve
Willowwood Global LLC
ONE-TTVD-MP-LG
In Commercial Distribution

  • 00194711301430 ()
ONE-TTVD-MP-LG

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TT System, LimbLogic Distal, Medium Liner, Small Sleeve
Willowwood Global LLC
ONE-TTVD-MD-SM
In Commercial Distribution

  • 00194711301423 ()
ONE-TTVD-MD-SM

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TT System, LimbLogic Distal, Medium Liner, Medium Sleeve
Willowwood Global LLC
ONE-TTVD-MD-MD
In Commercial Distribution

  • 00194711301416 ()
ONE-TTVD-MD-MD

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TT System, LimbLogic Distal, Large Plus Liner, Extra Large Sleeve
Willowwood Global LLC
ONE-TTVD-LP-XL
In Commercial Distribution

  • 00194711301409 ()
ONE-TTVD-LP-XL

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TT System, LimbLogic Distal, Large Plus Liner, Large Sleeve
Willowwood Global LLC
ONE-TTVD-LP-LG
In Commercial Distribution

  • 00194711301393 ()
ONE-TTVD-LP-LG

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TT System, LimbLogic Distal, Large Liner, Extra Large Sleeve
Willowwood Global LLC
ONE-TTVD-LG-XL
In Commercial Distribution

  • 00194711301386 ()
ONE-TTVD-LG-XL

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TT System, LimbLogic Distal, Large Liner, Medium Sleeve
Willowwood Global LLC
ONE-TTVD-LG-MD
In Commercial Distribution

  • 00194711301379 ()
ONE-TTVD-LG-MD

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TT System, LimbLogic Distal, Large Liner, Large Sleeve
Willowwood Global LLC
ONE-TTVD-LG-LG
In Commercial Distribution

  • 00194711301362 ()
ONE-TTVD-LG-LG

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Side, SmartTemp, Extra Large
Willowwood Global LLC
ONE-TFVS-XL-S
In Commercial Distribution

  • 00194711301218 ()
ONE-TFVS-XL-S

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Side, Alpha Duo, Extra Large
Willowwood Global LLC
ONE-TFVS-XL-D
In Commercial Distribution

  • 00194711301201 ()
ONE-TFVS-XL-D

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Side, SmartTemp, Medium Plus
Willowwood Global LLC
ONE-TFVS-MP-S
In Commercial Distribution

  • 00194711301195 ()
ONE-TFVS-MP-S

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Side, Alpha Duo, Medium Plus
Willowwood Global LLC
ONE-TFVS-MP-D
In Commercial Distribution

  • 00194711301188 ()
ONE-TFVS-MP-D

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Side, SmartTemp, Large Plus
Willowwood Global LLC
ONE-TFVS-LP-S
In Commercial Distribution

  • 00194711301171 ()
ONE-TFVS-LP-S

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Side, Alpha Duo, Large Plus
Willowwood Global LLC
ONE-TFVS-LP-D
In Commercial Distribution

  • 00194711301164 ()
ONE-TFVS-LP-D

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Side, SmartTemp, Large
Willowwood Global LLC
ONE-TFVS-LG-S
In Commercial Distribution

  • 00194711301157 ()
ONE-TFVS-LG-S

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Side, Alpha Duo, Large
Willowwood Global LLC
ONE-TFVS-LG-D
In Commercial Distribution

  • 00194711301140 ()
ONE-TFVS-LG-D

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Distal, SmartTemp, Extra Large
Willowwood Global LLC
ONE-TFVD-XL-S
In Commercial Distribution

  • 00194711301133 ()
ONE-TFVD-XL-S

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Distal, Alpha Duo, Extra Large
Willowwood Global LLC
ONE-TFVD-XL-D
In Commercial Distribution

  • 00194711301126 ()
ONE-TFVD-XL-D

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Distal, SmartTemp, Medium Plus
Willowwood Global LLC
ONE-TFVD-MP-S
In Commercial Distribution

  • 00194711301119 ()
ONE-TFVD-MP-S

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Distal, Alpha Duo, Medium Plus
Willowwood Global LLC
ONE-TFVD-MP-D
In Commercial Distribution

  • 00194711301102 ()
ONE-TFVD-MP-D

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Distal, SmartTemp, Large Plus
Willowwood Global LLC
ONE-TFVD-LP-S
In Commercial Distribution

  • 00194711301096 ()
ONE-TFVD-LP-S

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Distal, Alpha Duo, Large Plus
Willowwood Global LLC
ONE-TFVD-LP-D
In Commercial Distribution

  • 00194711301089 ()
ONE-TFVD-LP-D

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
One TF System, LimbLogic Distal, SmartTemp, Large
Willowwood Global LLC
ONE-TFVD-LG-S
In Commercial Distribution

  • 00194711301072 ()
ONE-TFVD-LG-S

  • External lower-limb prosthesis suspensory component, powered
  • External lower-limb prosthesis socket, non-customized
  • External lower-limb prosthesis socket, custom-made
  • External limb prosthesis socket liner
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