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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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Suction bag with solidifier 1.5l - 07612367031332

Suction bag with solidifier 1.5l for disposable collection system
Medela AG
077.0084
In Commercial Distribution

  • 07612367031714 ()
  • 07612367031332 ()
  • 07612367013796 ()


  • Suction system canister liner

Thopaz disposable canister with 0.3l - 07612367014212

Canister for thoracic suction systempump
Medela AG
079.0012
In Commercial Distribution

  • 07612367038669 ()
  • 07612367014212 ()
  • 07612367063364 ()


  • Surgical suction system collection container, single-use

Armboard short with short post - 07350111830434

No Description
Reison Medical AB
10-380-KR
In Commercial Distribution

  • 07350111830434 ()


  • Arm procedure positioner, reusable

Armboard short with long post - 07350111830427

No Description
Reison Medical AB
10-380-KL
In Commercial Distribution

  • 07350111830427 ()


  • Arm procedure positioner, reusable

Profin with IPR Lamineer Tips - 07350081496746

Profin PDX Reciprocating Contra/Angle E-Type with 5x Assorted Inter-Proximal Reduction Lamineer Tips 1 of each of the following: 0.1mm Blade Thickness, Double Sided 15 Micron Diamond Coating 0.2mm Blade Thickness, Double Sided 40 Micron Diamond Coating 0.3mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.4mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.5mm Blade Thickness, Double Sided 50 Micron Diamond Coating
Dentatus AB
PDX-P/SK2
In Commercial Distribution

  • 07350081496746 ()
PDX-P/SK2

  • Dental surgical power tool motorized handpiece/set, electric
  • Interproximal reduction kit

Anesthesia Armboard with 2" Pad - 00810105030280

Carbon Fiber construction Armboard designed to integrate with surgical table side rail and support the patient arm for surgical procedures.
COMPOSITE MANUFACTURING, INC.
1-1009-003
In Commercial Distribution

  • 00810105030280 ()


  • Armboard, reusable

BodyGuard® Microset with Filter - B101A120160XSFK0

110 in. (280 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XSFK
Not in Commercial Distribution

  • B101A120160XSFK1 ()
  • B101A120160XSFK0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with Filter - B101A120160XSFE0

134 in. (340 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XSFE
Not in Commercial Distribution

  • B101A120160XSFE1 ()
  • B101A120160XSFE0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with Filter - B101A120112XSFK0

110 in. (280 cm) - blue stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-112XSFK
Not in Commercial Distribution

  • B101A120112XSFK1 ()
  • B101A120112XSFK0 ()


  • Electric infusion pump administration set, single-use

BodyGuard® Microset with Filter - B101A100164XESF0

105 in. (270 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-164XESF
Not in Commercial Distribution

  • B101A100164XESF0 ()
  • B101A100164XESF1 ()


  • Electric infusion pump administration set, single-use
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