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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SK3500-Q1.5-DBCBVHLA - TABLEPAD SKYTRON 3500 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SK3500-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012344 ()


  • Operating table mattress, basic
SK6500-Q1.5-DBCBVHLA - TABLEPAD SKYTRON 6500 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SK6500-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012313 ()


  • Operating table mattress, basic
SK6001-Q1.5-DBCBVHLA - TABLEPAD SKYTRON 6001 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SK6001-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012283 ()


  • Operating table mattress, basic
SK5001-Q1.5-DBCBVHLA - TABLEPAD SKYTRON 5001 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SK5001-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012252 ()


  • Operating table mattress, basic
SK6500-Q1.5-DBCBVHLA - TABLEPAD SKYTRON 6500 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SK6500-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012191 ()


  • Operating table mattress, basic
SK6600-Q1.5-DBCBVHLA - TABLEPAD SKYTRON 6600 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SK6600-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012160 ()


  • Operating table mattress, basic
SK6701-Q1.5-DBCBVHLA - TABLEPAD SKYTRON 6701 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SK6701-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012139 ()


  • Operating table mattress, basic
SK6700-Q1.5-DBCBVHLA - TABLEPAD SKYTRON 6700 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SK6700-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012108 ()


  • Operating table mattress, basic
SK3600-Q1.5-DBCBVHLA - TABLEPAD SKYTRON 3600 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SK3600-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012078 ()


  • Operating table mattress, basic
SH4900-Q1.5-DBCBVHLA - TABLEPAD SHAMPAINE 4900 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SH4900-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012047 ()


  • Operating table mattress, basic
AM3085-Q1.5-DBCBVHLA - TABLEPAD AMSCO 3085 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
AM3085-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513012016 ()


  • Operating table mattress, basic
AM3080-Q1.5-DBCBVHLA - TABLEPAD AMSCO 3080 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
AM3080-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513011989 ()


  • Operating table mattress, basic
SK3100-Q1.5-DBCBVHLA - TABLEPAD SKYTRON 3100 Q 1.5" DARTEX BLACK CONDUCTIVE HL CLOSURE W / WO OUTLAST
BURLINGTON MEDICAL, LLC
SK3100-Q1.5-DBCBVHLA
In Commercial Distribution

  • 00197513011958 ()


  • Operating table mattress, basic
Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6914-NM
Not in Commercial Distribution

  • 50618029831021 ()
  • 00618029831026 ()
6914-NM

  • Basic manual toothbrush
  • Oral care swab
  • Dental suction system cannula, single-use
  • Oral care kit, single-use
  • Dental tooth-cleaning solution
Q Care, Q4 Oral Cleansing & Suctioning System, Petite, 0.12% Chlorhexidine Gluconate Oral Rinse and Corinz
SAGE PRODUCTS, LLC
6974
In Commercial Distribution

  • 50618029830970 ()
  • 00618029830975 ()
6974

  • Dental tooth-cleaning solution
  • Dental suction system cannula, single-use
  • Oral care swab
  • Oral care kit, single-use
  • Basic manual toothbrush
Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6914
In Commercial Distribution

  • 50618029830178 ()
  • 00618029830173 ()
6914

  • Dental suction system cannula, single-use
  • Oral care kit, single-use
  • Basic manual toothbrush
  • Oral care swab
  • Dental tooth-cleaning solution
Q Care Rx, Q2, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6912
In Commercial Distribution

  • 50618029830161 ()
  • 00618029830166 ()
6912

  • Basic manual toothbrush
  • Dental tooth-cleaning solution
  • Oral care swab
  • Dental suction system cannula, single-use
  • Oral care kit, single-use
Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6904
In Commercial Distribution

  • 50618029830086 ()
  • 00618029830081 ()
6904

  • Basic manual toothbrush
  • Dental tooth-cleaning solution
  • Oral care swab
  • Dental suction system cannula, single-use
  • Oral care kit, single-use
BURR HOLE COVER, LOW PROFILE, Q STYLE, 5 ARMS, 11 MM CUP, NEURO SCREW, TI-6AL-4V
KLS-Martin L.P.
01-300-21-91
Not in Commercial Distribution

  • 00888118005786 ()

  • 4 HOLE, 21 MM DIA, T=0.4 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
BURR HOLE COVER, LOW PROFILE, Q STYLE, 5 ARMS, 11 MM CUP, NEURO SCREW, TI-6AL-4V
KLS-Martin L.P.
01-300-22-91
Not in Commercial Distribution

  • 00888118005793 ()

  • 8 HOLE, 21 MM DIA, T=0.4 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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