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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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VINYL EXAMINATION GLOVES POWDER FREE WHITE (SMALL)
Mexpo International Inc.
BM 5226-WOP-PF
In Commercial Distribution

  • 10723860052268 ()
  • 00723860052261 ()
BM 5226-WOP-PF

  • Vinyl examination/treatment glove, non-powdered
VINYL EXAMINATION GLOVES POWDER FREE WHITE (X-SMALL)
Mexpo International Inc.
BM 5225-WOP-PF
In Commercial Distribution

  • 10723860052251 ()
  • 00723860052254 ()
BM 5225-WOP-PF

  • Vinyl examination/treatment glove, non-powdered
PALM TEXTURED NITRILE EXAMINATION GLOVES POWDER FREE BLUE (X-LARGE)
Mexpo International Inc.
BM 4229-N-PF
In Commercial Distribution

  • 10723860042290 ()
  • 00723860042293 ()
BM 4229-N-PF

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
PALM TEXTURED NITRILE EXAMINATION GLOVES POWDER FREE BLUE (LARGE)
Mexpo International Inc.
BM 4228-N-PF
In Commercial Distribution

  • 10723860042283 ()
  • 00723860042286 ()
BM 4228-N-PF

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
PALM TEXTURED NITRILE EXAMINATION GLOVES POWDER FREE BLUE (MEDIUM)
Mexpo International Inc.
BM 4227-N-PF
In Commercial Distribution

  • 10723860042276 ()
  • 00723860042279 ()
BM 4227-N-PF

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
PALM TEXTURED NITRILE EXAMINATION GLOVES POWDER FREE BLUE (SMALL)
Mexpo International Inc.
BM 4226-N-PF
In Commercial Distribution

  • 10723860042269 ()
  • 00723860042262 ()
BM 4226-N-PF

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
RUBBER DENTAL DAM - LIGHT BLUE- (6X6)
Mexpo International Inc.
BM 1666-RD DAM
In Commercial Distribution

  • 10723860016666 ()
  • 00723860016669 ()
BM 1666-RD DAM

  • Rubber dam, Hevea-latex
RUBBER DENTAL DAM - LIGHT BLUE- (5X5)
Mexpo International Inc.
BM1655-RD DAM
In Commercial Distribution

  • 10723860016550 ()
  • 00723860016553 ()
BM1655-RD DAM

  • Rubber dam, Hevea-latex
RUBBER DENTAL DAM - BLACK- (6X6)
Mexpo International Inc.
BM 1566-RD DAM BLK
In Commercial Distribution

  • 10723860015669 ()
  • 00723860015662 ()
BM 1566-RD DAM BLK

  • Rubber dam, Hevea-latex
RUBBER DENTAL DAM - BLACK- (5X5)
Mexpo International Inc.
BM 1555-RD DAM BLK
In Commercial Distribution

  • 10723860015553 ()
  • 00723860015556 ()
BM 1555-RD DAM BLK

  • Rubber dam, Hevea-latex
RUBBER DENTAL DAM - BLUE- (5X5)
Mexpo International Inc.
BM1355B-RD DAM
In Commercial Distribution

  • 10723860014556 ()
  • 00723860014559 ()
BM1355B-RD DAM

  • Rubber dam, Hevea-latex
RUBBER DENTAL DAM - BLUE- (6X6)
Mexpo International Inc.
BM1366B-RD DAM
In Commercial Distribution

  • 10723860013665 ()
  • 00723860013668 ()
BM1366B-RD DAM

  • Rubber dam, Hevea-latex
RUBBER DENTAL DAM - GREEN MINT- (6X6)
Mexpo International Inc.
BM 1366-RD DAM
In Commercial Distribution

  • 10723860013344 ()
  • 00723860013347 ()
BM 1366-RD DAM

  • Rubber dam, Hevea-latex
RUBBER DENTAL DAM - GREEN MINT- (5X5)
Mexpo International Inc.
BM 1355-RD DAM
In Commercial Distribution

  • 10723860013320 ()
  • 00723860013323 ()
BM 1355-RD DAM

  • Rubber dam, Hevea-latex
Single swab applicator - Dentin desensitizing liquid formula
BEUTLICH PHARMACEUTICALS, LLC
Snap-N-Go Swab
In Commercial Distribution

  • 02723797697113 ()
  • 00723797697115 ()
  • 02723797697588 ()
  • 01723797697589 ()
  • 01723797697114 ()
  • 01723797697473 ()
  • 10723797697587 ()
  • 20723797697584 ()
  • 10723797697471 ()
  • 20723797697119 ()


  • Dental coating, tooth-desensitizing, professional
Two-Tone Dental Plaque Disclosing Liquid; swab, each
BEUTLICH PHARMACEUTICALS, LLC
base unit
Not in Commercial Distribution

  • 02723797110575 ()
  • 01723797110576 ()
  • 00723797110515 ()


  • Dental caries detecting stain
HurriView Plaque Disclosing Liquid - swab, each
BEUTLICH PHARMACEUTICALS, LLC
base unit
Not in Commercial Distribution

  • 02723797104727 ()
  • 01723797104728 ()
  • 00723797010419 ()


  • Dental caries detecting stain
Tangle® Therapy
Tangle, Inc.
304
In Commercial Distribution

  • 00723459003049 ()


  • Finger/hand exerciser
Home pregnancy test for early results
Immunostics Company, Inc
2033
In Commercial Distribution

  • 00722355002873 ()
  • 80722355002879 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Home pregnancy test for early results
Immunostics Company, Inc
2030
In Commercial Distribution

  • 00722355002866 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Home pregnancy test for early results
Immunostics Company, Inc
5050M2-3B
In Commercial Distribution

  • 00722355002859 ()
  • 80722355002855 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Home pregnancy test for early results
Immunostics Company, Inc
5050M2-1B
In Commercial Distribution

  • 00722355002842 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Home pregnancy test for early results
Immunostics Company, Inc
IDP-3
In Commercial Distribution

  • 30722355001457 ()
  • 00722355001456 ()
  • 80722355001452 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
L-Cup Rapid Test w/ Adulteration (Urine). For the rapid detection of the following drugs in human urine: MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi
BTNX Inc
D12.11.1-1VLA
In Commercial Distribution

  • 10722066006754 ()
  • 00722066006757 ()
  • 20722066006751 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
L-Cup Home Rapid Test (Urine). For the rapid detection of the following drugs in human urine: AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25
BTNX Inc
D12.5.1-1VL
In Commercial Distribution

  • 10722066006747 ()
  • 00722066006740 ()
  • 20722066006744 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Drug Screening Cup (6.6.3) - AMP500 COC150 THC50 PCP25 MET500 OPI300
BTNX Inc
D6.6.3-1V
In Commercial Distribution

  • 00722066005514 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Drug Screening Cup (6.6.2) - AMP500 COC150 THC50 PCP25 MET500 OPI300
BTNX Inc
D6.6.2-1V
In Commercial Distribution

  • 00722066005507 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Rapid Response hCG Pregnancy Midstream Test is a rapid, self-performing, qualitative test for the determination of human chorionic gonadotropin in human urine specimens, to aid in the early detection of pregnancy.
BTNX Inc
HCG-1M1
In Commercial Distribution

  • 00722066005323 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
3 Panel One Step DOA Cup(3.36) - COC300 AMP1000 MET1000
BTNX Inc
D3.36-1V
In Commercial Distribution

  • 00722066005309 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 11 Parameter Urinalysis Reagent Strips (ASC/GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Ascorbic Acid, Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine.
BTNX Inc
U11.1-1S100
In Commercial Distribution

  • 00722066005255 ()
  • 00722066005262 ()


  • Urine specific gravity IVD, kit, rapid colorimetric, clinical
  • Urine pH IVD, kit, rapid colorimetric, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Urine blood IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical
  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • Urine ketone IVD, kit, rapid colorimetric, clinical
  • Urine urobilinogen IVD, kit, rapid colorimetric, clinical
  • Urine bilirubin IVD, kit, rapid colorimetric, clinical
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