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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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Cool Cassette 14 Instrument Container Green - 00723896001318

As the world's first flexible silicone instrument containers, Cool Cassettes will save your hands from heat and sharp edges, save workspace, save instruments from scratches—and save you money!Smooth, soft-touch Cool Cassettes are superior to metal cassettes in many ways:Cooler—Solid silicone construction dissipates heat faster than steel for faster removal from the autoclave.Safer—No sharp edges that can tear gloves and pouches or injure hands.Quieter—No metal surfaces to create noise or scratch instruments and mirrors.Easier to open—Snap on lids "peel off" easily yet hold securely. Two safety bands included add extra security when storing the containers on their sides.More compact—Lids stack underneath to reduce tray workspace requirements.Longer-lasting—No hinges, locks or moving parts to break. More colorful—Color-coded for operatory or instrument setups.Lighter—10% lighter weight than equivalent steel cassettes.Lower cost—About 40% less than equivalent steel cassettes.Due to their solid silicone construction, interior instrument saddles can be cut with scissors to accommodate large-handled instruments, if desired. All containers hold instruments up to 7-1⁄8" long. Fully sterilizable to 375°F.The Cool Cassette 14 Instrument Container includes two A-W syringe tip clips. Measures 8"L x 8-1⁄8"W x 1-3⁄8"H outside.
PRACTICON, INC.
7039772 GRE
In Commercial Distribution

  • 00723896001318 ()
70-39772 GRE

  • Instrument tray, reusable

Cool Cassette 14 Instrument Container Blue - 00723896001301

As the world's first flexible silicone instrument containers, Cool Cassettes will save your hands from heat and sharp edges, save workspace, save instruments from scratches—and save you money!Smooth, soft-touch Cool Cassettes are superior to metal cassettes in many ways:Cooler—Solid silicone construction dissipates heat faster than steel for faster removal from the autoclave.Safer—No sharp edges that can tear gloves and pouches or injure hands.Quieter—No metal surfaces to create noise or scratch instruments and mirrors.Easier to open—Snap on lids "peel off" easily yet hold securely. Two safety bands included add extra security when storing the containers on their sides.More compact—Lids stack underneath to reduce tray workspace requirements.Longer-lasting—No hinges, locks or moving parts to break.More colorful—Color-coded for operatory or instrument setups.Lighter—10% lighter weight than equivalent steel cassettes.Lower cost—About 40% less than equivalent steel cassettes. Due to their solid silicone construction, interior instrument saddles can be cut with scissors to accommodate large-handled instruments, if desired. All containers hold instruments up to 7-1⁄8" long. Fully sterilizable to 375°F.The Cool Cassette 14 Instrument Container includes two A-W syringe tip clips. Measures 8"L x 8-1⁄8"W x 1-3⁄8"H outside.
PRACTICON, INC.
7039772 BLU
In Commercial Distribution

  • 00723896001301 ()
70-39772 BLU

  • Instrument tray, reusable

Cool Cassette 10 Instrument Container Purple - 00723896001295

As the world's first flexible silicone instrument containers, Cool Cassettes will save your hands from heat and sharp edges, save workspace, save instruments from scratches—and save you money!Smooth, soft-touch Cool Cassettes are superior to metal cassettes in many ways:Cooler—Solid silicone construction dissipates heat faster than steel for faster removal from the autoclave.Safer—No sharp edges that can tear gloves and pouches or injure hands.Quieter—No metal surfaces to create noise or scratch instruments and mirrors.Easier to open—Snap on lids "peel off" easily yet hold securely. Two safety bands included add extra security when storing the containers on their sides.More compact—Lids stack underneath to reduce tray workspace requirements.Longer-lasting—No hinges, locks or moving parts to break.More colorful—Color-coded for operatory or instrument setups.Lighter—10% lighter weight than equivalent steel cassettes.Lower cost—About 40% less than equivalent steel cassettes. Due to their solid silicone construction, interior instrument saddles can be cut with scissors to accommodate large-handled instruments, if desired. All containers hold instruments up to 7-1⁄8" long. Fully sterilizable to 375°F.The Cool Cassette 5 Instrument Container includes one A-W syringe tip clip. Measures 8"L x 3-5⁄8"W x 1-3⁄8"H outside. Specify color.
PRACTICON, INC.
7039771 PUR
In Commercial Distribution

  • 00723896001295 ()
70-39771 PUR

  • Instrument tray, reusable

Cool Cassette 10 Instrument Container Green - 00723896001288

As the world's first flexible silicone instrument containers, Cool Cassettes will save your hands from heat and sharp edges, save workspace, save instruments from scratches—and save you money!Smooth, soft-touch Cool Cassettes are superior to metal cassettes in many ways:Cooler—Solid silicone construction dissipates heat faster than steel for faster removal from the autoclave.Safer—No sharp edges that can tear gloves and pouches or injure hands.Quieter—No metal surfaces to create noise or scratch instruments and mirrors.Easier to open—Snap on lids "peel off" easily yet hold securely. Two safety bands included add extra security when storing the containers on their sides.More compact—Lids stack underneath to reduce tray workspace requirements.Longer-lasting—No hinges, locks or moving parts to break.More colorful—Color-coded for operatory or instrument setups.Lighter—10% lighter weight than equivalent steel cassettes.Lower cost—About 40% less than equivalent steel cassettes. Due to their solid silicone construction, interior instrument saddles can be cut with scissors to accommodate large-handled instruments, if desired. All containers hold instruments up to 7-1⁄8" long. Fully sterilizable to 375°F.The Cool Cassette 5 Instrument Container includes one A-W syringe tip clip. Measures 8"L x 3-5⁄8"W x 1-3⁄8"H outside. Specify color.
PRACTICON, INC.
7039771 GRE
In Commercial Distribution

  • 00723896001288 ()
70-39771 GRE

  • Instrument tray, reusable

Cool Cassette 10 Instrument Container Blue - 00723896001271

As the world's first flexible silicone instrument containers, Cool Cassettes will save your hands from heat and sharp edges, save workspace, save instruments from scratches—and save you money!Smooth, soft-touch Cool Cassettes are superior to metal cassettes in many ways:Cooler—Solid silicone construction dissipates heat faster than steel for faster removal from the autoclave.Safer—No sharp edges that can tear gloves and pouches or injure hands.Quieter—No metal surfaces to create noise or scratch instruments and mirrors.Easier to open—Snap on lids "peel off" easily yet hold securely. Two safety bands included add extra security when storing the containers on their sides.More compact—Lids stack underneath to reduce tray workspace requirements.Longer-lasting—No hinges, locks or moving parts to break.More colorful—Color-coded for operatory or instrument setups.Lighter—10% lighter weight than equivalent steel cassettes.Lower cost—About 40% less than equivalent steel cassettes. Due to their solid silicone construction, interior instrument saddles can be cut with scissors to accommodate large-handled instruments, if desired. All containers hold instruments up to 7-1⁄8" long. Fully sterilizable to 375°F.The Cool Cassette 5 Instrument Container includes one A-W syringe tip clip. Measures 8"L x 3-5⁄8"W x 1-3⁄8"H outside. Specify color.
PRACTICON, INC.
7039771 BLU
In Commercial Distribution

  • 00723896001271 ()
70-39771 BLU

  • Instrument tray, reusable

Cool Cassette 5 Instrument Container Purple - 00723896000069

As the world's first flexible silicone instrument containers, Cool Cassettes will save your hands from heat and sharp edges, save workspace, save instruments from scratches—and save you money!Smooth, soft-touch Cool Cassettes are superior to metal cassettes in many ways:Cooler—Solid silicone construction dissipates heat faster than steel for faster removal from the autoclave.Safer—No sharp edges that can tear gloves and pouches or injure hands.Quieter—No metal surfaces to create noise or scratch instruments and mirrors.Easier to open—Snap on lids "peel off" easily yet hold securely. Two safety bands included add extra security when storing the containers on their sides.More compact—Lids stack underneath to reduce tray workspace requirements.Longer-lasting—No hinges, locks or moving parts to break.More colorful—Color-coded for operatory or instrument setups.Lighter—10% lighter weight than equivalent steel cassettes.Lower cost—About 40% less than equivalent steel cassettes. Due to their solid silicone construction, interior instrument saddles can be cut with scissors to accommodate large-handled instruments, if desired. All containers hold instruments up to 7-1⁄8" long. Fully sterilizable to 375°F.The Cool Cassette 5 Instrument Container includes one A-W syringe tip clip. Measures 8"L x 3-5⁄8"W x 1-3⁄8"H outside. Specify color.
PRACTICON, INC.
7039770 PUR
In Commercial Distribution

  • 00723896000069 ()
70-39770 PUR

  • Instrument tray, reusable

HurriView II - 00723797110515

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

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


  • Dental caries detecting stain

L-Cup - 00722066006757

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 - 00722066006740

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 - 00722066005309

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 - 00722066005255

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

Rapid Response - 00722066005095

One Step 5 Panel DOA Cup (5.75) - COC300 MET1000 AMP1000 OPI2000 OXY100
BTNX Inc
D5.75-1V
In Commercial Distribution

  • 00722066005095 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066005088

One Step 10 Panel DOA Cup (10.32) - COC300 MET1000 AMP1000 OPI2000 OXY100 MTD300 PCP25 BAR300 BZO300 MDMA500
BTNX Inc
D10.32-1V
In Commercial Distribution

  • 00722066005088 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066005019

One Step DOA Cup + Adulteration Test (5.30.1) COC(150) EDDP(100) MOP(100) OXY(100) BZO(300) + CR/SG/pH
BTNX Inc
D5.30.1-1VA
In Commercial Distribution

  • 00722066005019 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004951

Single Drug Test Strip - 100/kit Methadone (MTD) - Cut-off 300 ng/ml
BTNX Inc
MTD-1S3-100
In Commercial Distribution

  • 00722066004951 ()
  • 00722066004944 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004913

10 Panel One Step DOA Cup(10.3.1) - COC150 AMP500 MET500 THC50 MOP2000 PCP25 BAR300 BZO300 MTD300 MDMA500
BTNX Inc
D10.3.1-1V
In Commercial Distribution

  • 00722066004913 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004906

One Step 12 Panel DOA Cup + Adulteration Test (12.11.1) - MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi
BTNX Inc
D12.11.1-1VA
In Commercial Distribution

  • 00722066004906 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004890

One Step 10 Panel DOA Cup (10.14.1) - COC150 AMP500 MET500 THC50 MTD300 MOP2000 OXY100 PCP25 BAR300 BZO300
BTNX Inc
D10.14.1-1V
In Commercial Distribution

  • 00722066004890 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004883

One Step 5 Panel DOA Cup (5.1.1) - COC150 AMP500 MET500 THC50 MOP2000
BTNX Inc
D5.1.1-1V
In Commercial Distribution

  • 00722066004883 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004876

One Step 12 Panel DOA Cup (12.5.1) - AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25
BTNX Inc
D12.5.1-1V
In Commercial Distribution

  • 00722066004876 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004784

10 Panel One Step DOA Cup (10.11) - COC(300) AMP(1000) MET(1000) THC(50) EDDP(300) MOP(300) OPI(2000) OXY(100) BZO(300) BUP(10)
BTNX Inc
D10.11-1V
In Commercial Distribution

  • 00722066004784 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004722

Rapid Response Multi-Drug One Step Cup - AMP1000 BAR300 BUP10 BZO300 COC300 MDMA500 MTD300 MET1000 OPI2000 OXY100 THC50 TCA1000
BTNX Inc
D12.21-1V
In Commercial Distribution

  • 00722066004722 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004678

One Step 9 Panel DOA Cup(9.11) - AMP1000, BUP10, BZO300, COC300, MTD300, MET1000, OPI2000, OXY100, THC50
BTNX Inc
D9.11-1V
In Commercial Distribution

  • 00722066004678 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004647

One Step 5 Panel DOA Cup (5.2) - COC300 AMP1000 THC50 OPI2000 PCP25
BTNX Inc
D5.2-1V
In Commercial Distribution

  • 00722066004647 ()
  • 00722066004739 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004630

7 Panel One Step DOA Cup
BTNX Inc
D7.3-1V
In Commercial Distribution

  • 00722066004630 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004616

Single Drug Test Strip - 100/kit Oxycodone
BTNX Inc
OXY-1S27-100
In Commercial Distribution

  • 00722066004616 ()
  • 00722066004623 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004593

10-Drug Test Panel - 25/kit(10.22) - COC300 AMP1000 MET1000 THC50 MTD300 MOP300 OXY100 BAR300 BZO300 BUP10
BTNX Inc
D10.22-1P29-25
In Commercial Distribution

  • 00722066004593 ()
  • 00722066004609 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004586

10 Panel One Step DOA Cup(10.3) - COC300 AMP1000 MET1000 THC50 OPI2000 PCP25 BAR300 BZO300 MTD300 MDMA500
BTNX Inc
D10.3-1V
In Commercial Distribution

  • 00722066004586 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004562

No Description
BTNX Inc
D12.11-1VA
In Commercial Distribution

  • 00722066004562 ()
  • 00722066004579 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 00722066004548

No Description
BTNX Inc
D12.5-1V
In Commercial Distribution

  • 00722066004548 ()
  • 00722066004555 ()
  • 17220660045481 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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