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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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TopCare health - 00036800216594

Sterile, Antibacterial, Bandage Roll, 1 roll, 4 1/2 IN x 4.1 YDS. Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
Topco Associates, LLC
036800216594
In Commercial Distribution

  • 10036800216591 ()
  • 00036800216594 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial

TopCare - 00036800007659

Antibacterial Rapid-Seal Wound Gel, 0.5 FL OZ (14 mL)
Topco Associates, LLC
036800007659
In Commercial Distribution

  • 10036800007656 ()
  • 00036800007659 ()


  • Chitosan haemostatic agent, home-use

Dentek - 00047701004654

DNTK READY FIT 16CT DNTL GRD 12
DenTek Oral Care, Inc.
00046501202A
In Commercial Distribution

  • 30047701004655 ()
  • 00047701004654 ()


  • Custom-made mouthguard

Dentek - 00047701002773

DNTK MAX PROTECT DNTL GRD 12
DenTek Oral Care, Inc.
00027701203G
In Commercial Distribution

  • 50047701002778 ()
  • 00047701002773 ()


  • Custom-made mouthguard

Dentek - 00047701001752

DNTK FRSH PROTECT 16CT GRD 12
DenTek Oral Care, Inc.
10047701001759
In Commercial Distribution

  • 10047701001759 ()
  • 00047701001752 ()


  • Custom-made mouthguard

Dentek - 00047701001516

DNTK CMF FIT 2CT DNTL GRD 12
DenTek Oral Care, Inc.
00015101203I2
In Commercial Distribution

  • 40047701001514 ()
  • 00047701001516 ()


  • Custom-made mouthguard

Dentek - 00047701001325

DNTK FRSH PROTECT 6CT GRD 12
DenTek Oral Care, Inc.
10047701001322
In Commercial Distribution

  • 00047701001325 ()
  • 10047701001322 ()


  • Custom-made mouthguard

Dentek - 00047701001202

DNTK CANKER RELIEF 6CT PATCH 24
DenTek Oral Care, Inc.
00038904806A
In Commercial Distribution

  • 10047701001209 ()
  • 00047701001202 ()


  • Orthodontic appliance relief material

Dentek - 00047701000557

DNTK FRSH PROTECT 32CT GRD 12
DenTek Oral Care, Inc.
10047701000554
In Commercial Distribution

  • 00047701000557 ()
  • 10047701000554 ()


  • Custom-made mouthguard

Dentek - 00047701000410

DNTK ULTIMATE 1CT DNTL GRD CND 12
DenTek Oral Care, Inc.
10047701000417
In Commercial Distribution

  • 10047701000417 ()
  • 00047701000410 ()


  • Custom-made mouthguard
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