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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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DNTK ULTIMATE 1CT DNTL GRD 12
DenTek Oral Care, Inc.
10047701000400A
In Commercial Distribution

  • 10047701000400 ()
  • 00047701000403 ()


  • Custom-made mouthguard
TD NIGHTGUARD ADVANCED CND 12
Medtech Products Inc.
79932E
In Commercial Distribution

  • 10042037799325 ()
  • 00042037799328 ()


  • Custom-made mouthguard
TD NGHTGRD ADV 1CT PAD 12
Medtech Products Inc.
79922B
In Commercial Distribution

  • 10042037101432 ()
  • 00042037799229 ()


  • Custom-made mouthguard
Antibacterial Bandage Roll, one roll, 4.5 IN x 4.1 YDS. Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
Ahold U.S.A., Inc.
041520078179
In Commercial Distribution

  • 10041520078176 ()
  • 00041520078179 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
FCI S A S FCI 20 22
S1.1550
In Commercial Distribution

  • 13700773723277 ()
  • 03700773723270 ()


  • Lacrimal intubation set
A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
FCI S A S FCI 20 22
S1.1545
In Commercial Distribution

  • 13700773723260 ()
  • 03700773723263 ()


  • Lacrimal intubation set
A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
FCI S A S FCI 20 22
S1.1522
In Commercial Distribution

  • 13700773723253 ()
  • 03700773723256 ()


  • Lacrimal intubation set
A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
FCI S A S FCI 20 22
S1.1515
In Commercial Distribution

  • 13700773723246 ()
  • 03700773723249 ()


  • Lacrimal intubation set
CANALICULAR PLUG
RIVERPOINT MEDICAL, LLC
58144
In Commercial Distribution

  • 10840277405125 ()
  • 00840277405128 ()


  • Lacrimal punctum plug
CANALICULAR PLUG
RIVERPOINT MEDICAL, LLC
58143
In Commercial Distribution

  • 10840277405118 ()
  • 00840277405111 ()


  • Lacrimal punctum plug
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