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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3M™ Curos™ Tips™ Disinfecting Cap Strip for Male Luers US - CM5-200
3M COMPANY
CM5-200
In Commercial Distribution

  • 50707387773798 ()
  • 30707387773794 ()
  • 00707387773793 ()
CM5-200

  • Luer-formatted disinfection cap
3M™ Curos™ Disinfecting Cap Strip for Needleless Connectors US - CFF10- 250
3M COMPANY
CFF10-250
In Commercial Distribution

  • 50707387773774 ()
  • 30707387773770 ()
  • 00707387773779 ()
CFF10-250

  • Luer-formatted disinfection cap
3M™ Curos™ Disinfecting Cap for Needleless Connectors 270/Carton 20 Cartons/Case CFF1-270
3M COMPANY
CFF1-270
In Commercial Distribution

  • 50707387773750 ()
  • 30707387773756 ()
  • 00707387773779 ()
CFF1-270

  • Luer-formatted disinfection cap
SwabTip Strip
ICU MEDICAL, INC.
SWTP-5
In Commercial Distribution

  • 30887709097828 ()
  • 20887709097821 ()
  • 00887709097827 ()
  • 10887709097824 ()
SWTP-5

  • Luer-formatted disinfection cap
ClearGuard® HD
ICU MEDICAL, INC.
011-CGHD-100
In Commercial Distribution

  • 10887709123592 ()
  • 00887709123595 ()
011-CGHD-100

  • Luer-formatted disinfection cap
ClearGuard™ HD 100 Pack
ICU MEDICAL, INC.
CGHD-100
In Commercial Distribution

  • 10887709123585 ()
  • 00887709123588 ()
CGHD-100

  • Luer-formatted disinfection cap
Cap, Disinfecting for Needle Free Valves, Strip of 10
MCKESSON MEDICAL-SURGICAL INC.
421-SCXT3-10-2000
In Commercial Distribution

  • 30612479261656 ()
  • 20612479261642 ()
  • 40612479261660 ()
  • 10612479265858 ()


  • Luer-formatted disinfection cap
Cap, Disinfecting for Needle Free Valves
MCKESSON MEDICAL-SURGICAL INC.
421-SCXT3-2000
In Commercial Distribution

  • 40612479261639 ()
  • 20612479261628 ()
  • 10612479265841 ()


  • Luer-formatted disinfection cap
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours. ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs. The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae. The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution

  • B081CGHD108258208 ()


  • Luer-formatted disinfection cap
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours. ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs. The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae. The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution

  • B081CGHD108258211 ()


  • Luer-formatted disinfection cap
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours. ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs. The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae. The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution

  • B081CGHD108258210 ()


  • Luer-formatted disinfection cap
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours. ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs. The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae. The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution

  • B081CGHD108258209 ()


  • Luer-formatted disinfection cap
CAP DISINFECTION SINGLES US
BECTON, DICKINSON AND COMPANY
306596
In Commercial Distribution

  • 30382903065968 ()
  • 00382903065967 ()
  • 50382903065962 ()
306596

  • Luer-formatted disinfection cap
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours. ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs. The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae. The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution

  • B081CGHD108258212 ()


  • Luer-formatted disinfection cap
TG Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995465
In Commercial Distribution

  • 00630414597928 ()
10995465

  • Thyroglobulin antibody IVD, control
TG Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995464
In Commercial Distribution

  • 00630414597911 ()
10995464

  • Thyroglobulin antibody IVD, control
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4004
In Commercial Distribution

  • D800BSFE4004 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4003
In Commercial Distribution

  • D800BSFE4003 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4002
In Commercial Distribution

  • D800BSFE4002 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4001
In Commercial Distribution

  • D800BSFE4001 ()


  • Dental implant suprastructure, temporary, preformed, reusable
3M™ AlastiK™ Lingual Ligatures, 406-993, Navy Blue, 12/Stick, 12/Pk
3M UNITEK CORPORATION
406-993
In Commercial Distribution

  • 80652221227573 ()
  • 00652221227577 ()
406-993

  • Orthodontic archwire/bracket ligature
L6R HALO MOLAR BAND .022 SGL CV -20T BT W/CLEAT
Ortho Arch Company Inc
MOLAR BAND .022 -20T BT W/CLEAT
In Commercial Distribution

  • D909901961C1 ()
901-961C

  • Orthodontic metal band
L6R HALO MOLAR BAND .022 SGL CV -20T BT
Ortho Arch Company Inc
MOLAR BAND .022 -20T BT
In Commercial Distribution

  • D9099019611 ()
901-961

  • Orthodontic metal band
U6L HALO MOLAR BAND .022 SGL NON-CV -14T BT W/SHEATH
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT W/SHEATH
In Commercial Distribution

  • D909901943S1 ()
901-943S

  • Orthodontic metal band
U6L HALO MOLAR BAND .022 SGL NON-CV -14T BT W/CLEAT
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT W/CLEAT
In Commercial Distribution

  • D909901943C1 ()
901-943C

  • Orthodontic metal band
U67L HALO MOLAR BAND .022 SGL NON-CV -14T BT
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT
In Commercial Distribution

  • D9099019431 ()
901-943

  • Orthodontic metal band
U6R HALO MOLAR BAND .022 SGL NON-CV -14T BT W/SHEATH
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT W/SHEATH
In Commercial Distribution

  • D909901942S1 ()
901-942S

  • Orthodontic metal band
U6R HALO MOLAR BAND .022 SGL NON-CV -14T BT W/CLEAT
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT W/CLEAT
In Commercial Distribution

  • D909901942C1 ()
901-942C

  • Orthodontic metal band
U67R HALO MOLAR BAND .022 SGL NON-CV -14T BT
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT
In Commercial Distribution

  • D9099019421 ()
901-942

  • Orthodontic metal band
U6L HALO MOLAR BAND .022 SGL CV -14T BT W/SHEATH
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT W/SHEATH
In Commercial Distribution

  • D909901941S1 ()
901-941S

  • Orthodontic metal band
U6L HALO MOLAR BAND .022 SGL CV -14T BT W/CLEAT
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT W/CLEAT
In Commercial Distribution

  • D909901941C1 ()
901-941C

  • Orthodontic metal band
U6L HALO MOLAR BAND .022 SGL CV -14T BT
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT
In Commercial Distribution

  • D9099019411 ()
901-941

  • Orthodontic metal band
U6R HALO MOLAR BAND .022 SGL CV -14T BT W/SHEATH
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT W/SHEATH
In Commercial Distribution

  • D909901940S1 ()
901-940S

  • Orthodontic metal band
U6R HALO MOLAR BAND .022 SGL CV -14T BT W/CLEAT
Ortho Arch Company Inc
HALO MOLAR BAND .022 -14T BT W/CLEAT
In Commercial Distribution

  • D909901940C1 ()
901-940C

  • Orthodontic metal band
U6R HALO MOLAR BAND .022 SGL CV -14T BT
Ortho Arch Company Inc
MOLAR BAND .022 -14T BT
In Commercial Distribution

  • D9099019401 ()
901-940

  • Orthodontic metal band
L6L HALO MOLAR BAND .022 SGL CV -12T BT W/SHEATH M&D HK
Ortho Arch Company Inc
HALO MOLAR BAND .022 -12T BT W/SHEATH M&D HK
In Commercial Distribution

  • D909901932SH1 ()
901-932SH

  • Orthodontic metal band
L6L HALO MOLAR BAND .022 SGL CV -12T BT W/SHEATH
Ortho Arch Company Inc
HALO MOLAR BAND .022 -12T BT W/SHEATH
In Commercial Distribution

  • D909901932S1 ()
901-932S

  • Orthodontic metal band
L6L HALO MOLAR BAND .022 SGL CV -12T BT W/ LARGE CLEAT
Ortho Arch Company Inc
MOLAR BAND .022 -12T BT W/ LARGE CLEAT
In Commercial Distribution

  • D909901932LC11 ()
901-932LC

  • Orthodontic metal band
L6R HALO MOLAR BAND .022 SGL CV -12T BT W/SHEATH M&D HK
Ortho Arch Company Inc
MOLAR BAND .022 -12T BT W/SHEATH M&D HK
In Commercial Distribution

  • D909901931SH1 ()
901-931SH

  • Orthodontic metal band
L6R HALO MOLAR BAND .022 SGL CV -12T BT W/SHEATH
Ortho Arch Company Inc
MOLAR BAND .022 -12T BT W/SHEATH
In Commercial Distribution

  • D909901931S1 ()
901-931S

  • Orthodontic metal band
L6R HALO MOLAR BAND .022 SGL CV -12T BT W/ LARGE CLEAT
Ortho Arch Company Inc
MOLAR BAND .022 -12T BT W/ LARGE CLEAT
In Commercial Distribution

  • D909901931LC10 ()
901-931LC

  • Orthodontic metal band
U6L HALO MOLAR BAND .022 TPL CV HG TO OCCL -10T BT W/SHEATH
Ortho Arch Company Inc
MOLAR BAND .022 -10T BT W/SHEATH
In Commercial Distribution

  • D909901924S1 ()
901-924S

  • Orthodontic metal band
U6L HALO MOLAR BAND .022 TPL CV HG TO OCCL -10T BT W/CLEAT
Ortho Arch Company Inc
MOLAR BAND .022 -10T BT W/CLEAT
In Commercial Distribution

  • D909901924C1 ()
901-924C

  • Orthodontic metal band
U6L HALO MOLAR BAND .022 TPL CV HG TO OCCL -10T BT W/BUTTON
Ortho Arch Company Inc
MOLAR BAND .022 -10T BT W/BUTTON
In Commercial Distribution

  • D909901924B1 ()
901-924B

  • Orthodontic metal band
U6L HALO MOLAR BAND .022 TPL CV HG TO OCCL -10T BT
Ortho Arch Company Inc
MOLAR BAND .022 -10T BT
In Commercial Distribution

  • D9099019241 ()
901-924

  • Orthodontic metal band
U6R HALO MOLAR BAND .022 TPL CV HG TO OCCL -10T BT W/SHEATH
Ortho Arch Company Inc
MOLAR BAND .022 -10T BT W/SHEATH
In Commercial Distribution

  • D909901923S1 ()
901-923S

  • Orthodontic metal band
U6R HALO MOLAR BAND .022 TPL CV HG TO OCCL -10T BT W/CLEAT
Ortho Arch Company Inc
MOLAR BAND .022 -10T BT W/CLEAT
In Commercial Distribution

  • D909901923C1 ()
901-923C

  • Orthodontic metal band
U6R HALO MOLAR BAND .022 TPL CV HG TO OCCL -10T BT W/BUTTON
Ortho Arch Company Inc
MOLAR BAND .022 -10T BT W/BUTTON
In Commercial Distribution

  • D909901923B1 ()
901-923B

  • Orthodontic metal band
U6R HALO MOLAR BAND .022 TPL CV HG TO OCCL -10T BT
Ortho Arch Company Inc
MOLAR BAND .022 -10T BT
In Commercial Distribution

  • D9099019231 ()
901-923

  • Orthodontic metal band
U6L HALO MOLAR BAND .022 DBL CV AUX -10T BT W/CLEAT
Ortho Arch Company Inc
U6L MOLAR BAND .022 -10T BT W/CLEAT
In Commercial Distribution

  • D909901922C1 ()
901-922C

  • Orthodontic metal band
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