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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Erkoflex, 4.00 mm, Ø 120 mm, yolk yellow. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.
Erkodent Erich Kopp GmbH
584258
In Commercial Distribution

  • ERKO5842582 ()


  • Dental appliance fabrication material, thermoplastic
Erkoflex, 4.00 mm, Ø 120 mm, orange. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.
Erkodent Erich Kopp GmbH
584257
In Commercial Distribution

  • ERKO5842572 ()


  • Dental appliance fabrication material, thermoplastic
Erkoflex, 4.00 mm, Ø 120 mm, silver. Thermoforming sheet material for the fabrication of orthodontic and dental appliances
Erkodent Erich Kopp GmbH
584256
In Commercial Distribution

  • ERKO5842562 ()


  • Dental appliance fabrication material, thermoplastic
Exercise skin muscle equipment
ACTIVE OPTICAL SYSTEMS LTD
RF-311N
In Commercial Distribution

  • 07290016727036 ()


  • Multi-modality skin surface treatment system
No Description
QUALITY ELECTRODYNAMICS LLC
Q7000198
In Commercial Distribution

  • 00814848020546 ()


  • MRI system coil, radio-frequency
No Description
QUALITY ELECTRODYNAMICS LLC
Q7000199
In Commercial Distribution

  • 00814848020508 ()


  • MRI system coil, radio-frequency
Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 15.8ml pack size
Apatech Ltd
506005078068
In Commercial Distribution

  • 05060050780685 ()

  • Total Volume: 15.8 Milliliter
506005078068

  • Bone matrix implant, synthetic, non-antimicrobial
Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 8ml pack size
Apatech Ltd
506005078066
In Commercial Distribution

  • 05060050780661 ()

  • Total Volume: 8 Milliliter
506005078066

  • Bone matrix implant, synthetic, non-antimicrobial
Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 2.6ml pack size
Apatech Ltd
506005078064
In Commercial Distribution

  • 05060050780647 ()

  • Total Volume: 2.6 Milliliter
506005078064

  • Bone matrix implant, synthetic, non-antimicrobial
Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 1.6ml pack size
Apatech Ltd
506005078062
In Commercial Distribution

  • 05060050780623 ()

  • Total Volume: 1.6 Milliliter
506005078062

  • Bone matrix implant, synthetic, non-antimicrobial
Endodontic instrument for professionnal dental use only
MICRO MEGA
n025 L21
In Commercial Distribution

  • J015209490011 ()
  • J015209490019 ()
  • J015209490010 ()
20949001

  • Rotary/reciprocating endodontic file/rasp, single-use
No Description
BIOTEX, INC.
033-1000
Not in Commercial Distribution

  • M710SCVS0 ()
  • M710SCVS2 ()
SC-VS

  • Rigid non-bladed intubation laryngoscope, video
No Description
BIOTEX, INC.
033-6000-003
Not in Commercial Distribution

  • M710SCMR0 ()
SC-MR

  • Rigid non-bladed intubation laryngoscope, video
No Description
BIOTEX, INC.
033-6501
Not in Commercial Distribution

  • M710SCM0 ()
SC-M

  • Rigid non-bladed intubation laryngoscope, video
No Description
BIOTEX, INC.
033-6500
Not in Commercial Distribution

  • M710SCC0 ()
SC-C

  • Rigid non-bladed intubation laryngoscope, video
No Description
BIOTEX, INC.
033-5000
Not in Commercial Distribution

  • M710NDK2 ()
SC-NDK

  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Videolaryng.MAC#2
Karl Storz GmbH & Co. KG
8401KXC
In Commercial Distribution

  • 04048551011102 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Videolaryng. D-BLADE, Ped.
Karl Storz GmbH & Co. KG
8401HXP
In Commercial Distribution

  • 04048551348611 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC®Videolaryn.D-BLADE, Plastic Handle
Karl Storz GmbH & Co. KG
8401HX-1
In Commercial Distribution

  • 04048551347058 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MAC #2
Karl Storz GmbH & Co. KG
8403KXC
In Commercial Distribution

  • 04048551389539 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MAC #3
Karl Storz GmbH & Co. KG
8403AXC
In Commercial Distribution

  • 04048551389478 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MAC #4
Karl Storz GmbH & Co. KG
8403BX
In Commercial Distribution

  • 04048551389461 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MAC #4
Karl Storz GmbH & Co. KG
8403BXC
In Commercial Distribution

  • 04048551389454 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope D-BLADE
Karl Storz GmbH & Co. KG
8403HX
In Commercial Distribution

  • 04048551389447 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MAC #3
Karl Storz GmbH & Co. KG
8403AX
In Commercial Distribution

  • 04048551389430 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope D-BLADE, Ped.
Karl Storz GmbH & Co. KG
8403HXP
In Commercial Distribution

  • 04048551389423 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Videolaryng.MIL#0, Alu. Handle
Karl Storz GmbH & Co. KG
8401DXC
In Commercial Distribution

  • 04048551268971 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Videolaryng.MAC#1, Alu. Handle
Karl Storz GmbH & Co. KG
8401GXC
In Commercial Distribution

  • 04048551268964 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Videolaryng. D-BLADE
Karl Storz GmbH & Co. KG
8401HX
In Commercial Distribution

  • 04048551251935 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Video Laryngoscope MAC #0
Karl Storz GmbH & Co. KG
8403EXC
In Commercial Distribution

  • 04048551398562 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MIL #1
Karl Storz GmbH & Co. KG
8403GXC
In Commercial Distribution

  • 04048551396193 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MIL #0
Karl Storz GmbH & Co. KG
8403DXC
In Commercial Distribution

  • 04048551396025 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Video Laryngoscope MIL #2
Karl Storz GmbH & Co. KG
8403MXC
In Commercial Distribution

  • 04048551401477 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MAC #2
Karl Storz GmbH & Co. KG
8404KXC
In Commercial Distribution

  • 04048551442159 ()
8404KXC

  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MIL #1
Karl Storz GmbH & Co. KG
8404GXC
In Commercial Distribution

  • 04048551441978 ()
8404GXC

  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MIL #2
Karl Storz GmbH & Co. KG
8404MXC
In Commercial Distribution

  • 04048551441954 ()
8404MXC

  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MIL #0
Karl Storz GmbH & Co. KG
8404DXC
In Commercial Distribution

  • 04048551441947 ()
8404DXC

  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MAC #4
Karl Storz GmbH & Co. KG
8404BX
In Commercial Distribution

  • 04048551441930 ()
8404BX

  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MAC #4
Karl Storz GmbH & Co. KG
8404BXC
In Commercial Distribution

  • 04048551441923 ()
8404BXC

  • Rigid non-bladed intubation laryngoscope, video
C-MAC Videolaryngoskop MAC #3
Karl Storz GmbH & Co. KG
8404AXC
In Commercial Distribution

  • 04048551441909 ()
8404AXC

  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope D-BLADE, Ped.
Karl Storz GmbH & Co. KG
8404HXP
In Commercial Distribution

  • 04048551441879 ()
8404HXP

  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope D-BLADE
Karl Storz GmbH & Co. KG
8404HX
In Commercial Distribution

  • 04048551441862 ()
8404HX

  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MAC #3
Karl Storz GmbH & Co. KG
8404AX
In Commercial Distribution

  • 04048551441855 ()
8404AX

  • Rigid non-bladed intubation laryngoscope, video
C-MAC Video Laryngoscope MAC #0
Karl Storz GmbH & Co. KG
8404EXC
In Commercial Distribution

  • 04048551441992 ()
8404EXC

  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Videolaryng.MAC#4
Karl Storz GmbH & Co. KG
8401BXC
In Commercial Distribution

  • 04048551002438 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Videolaryng.MAC#3
Karl Storz GmbH & Co. KG
8401AXC
In Commercial Distribution

  • 04048551002421 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Videolaryng.MAC#4
Karl Storz GmbH & Co. KG
8401BX
In Commercial Distribution

  • 04048551002414 ()


  • Rigid non-bladed intubation laryngoscope, video
C-MAC® Videolaryng. MAC#3, Alu Handle
Karl Storz GmbH & Co. KG
8401AX
In Commercial Distribution

  • 04048551002407 ()


  • Rigid non-bladed intubation laryngoscope, video
Monitor with connecting and re-charging cables, to be used with video-stylet (comes with IV pole mount)
SMART VIDEO-STYLET, LLC
S-SC-NDK
In Commercial Distribution

  • B881SSCNDK0 ()
S-SC-NDK

  • Rigid non-bladed intubation laryngoscope, video
Phonak Charger CombiPlus no EPS
Sonova AG
075-0066-10
In Commercial Distribution

  • 07613389457124 ()
075-0066-10

  • Noninvasive device battery charger
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