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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BER11 SYNDESMOTOME
HU-FRIEDY MFG. CO., LLC
BER11
In Commercial Distribution

  • 10889950004767 ()
BER11

  • Syndesmotome
Slim Line Distal Cinch Back Hand Instr
HU-FRIEDY MFG. CO., LLC
678-506
In Commercial Distribution

  • 10889950003920 ()
678-506

  • Dental dressing forceps, reusable
Slim Direct Bond Bracket Holder Tweezers
HU-FRIEDY MFG. CO., LLC
678-504
In Commercial Distribution

  • 10889950003906 ()
678-504

  • Dental dressing forceps, reusable
Direct Bond Bracket Holder (tweezers)
HU-FRIEDY MFG. CO., LLC
678-212M
In Commercial Distribution

  • 10889950003425 ()
678-212M

  • Dental dressing forceps, reusable
#7 MINI SCALPEL BLADE HOLDER
HU-FRIEDY MFG. CO., LLC
10-130-70
In Commercial Distribution

  • 10889950003036 ()
10-130-70

  • Scalpel handle, reusable
No 5 European Style Matte Scalpel Handle
HU-FRIEDY MFG. CO., LLC
10-130-5EM
In Commercial Distribution

  • 10889950003029 ()
10-130-5EM

  • Scalpel handle, reusable
#7K Scalpel Handle
HU-FRIEDY MFG. CO., LLC
10-130-07K
In Commercial Distribution

  • 10889950003005 ()
10-130-07K

  • Scalpel handle, reusable
SCALPEL HANDLE NO. 5
HU-FRIEDY MFG. CO., LLC
10-130-05E
In Commercial Distribution

  • 10889950002985 ()
10-130-05E

  • Scalpel handle, reusable
#5 Scalpel Handle, Round
HU-FRIEDY MFG. CO., LLC
10-130-05A
In Commercial Distribution

  • 10889950002954 ()
10-130-05A

  • Scalpel handle, reusable
#3 Scalpel Handle
HU-FRIEDY MFG. CO., LLC
10-130-03
In Commercial Distribution

  • 10889950002930 ()
10-130-03

  • Scalpel handle, reusable
#4 Scalpel Handle
HU-FRIEDY MFG. CO., LLC
10-100-04
In Commercial Distribution

  • 10889950002923 ()
10-100-04

  • Scalpel handle, reusable
IMS Monitor Tape (Black)
HU-FRIEDY MFG. CO., LLC
IMS-1269
In Commercial Distribution

  • 10889950002466 ()
IMS-1269

  • Chemical/physical sterilization process indicator
IMS Monitor Tape (Blank)
HU-FRIEDY MFG. CO., LLC
IMS-1250
Not in Commercial Distribution

  • 10889950002282 ()
IMS-1250

  • Chemical/physical sterilization process indicator
3-0 BLACK SILK SUTURE 27", D-14 NEEDLE 17.5MM, 1/2 CIRCLE CUTTING END TAPER
HU-FRIEDY MFG. CO., LLC
PSN953S
In Commercial Distribution

  • 10889950000905 ()
  • 10889950002015 ()

  • 3-0
PSN953S

  • Silk suture
4-0 BLACK SILK SUTURE 27", D-14 NEEDLE 17.5MM, 1/2 CIRCLE CUTTING END TAPER
HU-FRIEDY MFG. CO., LLC
PSN952S
In Commercial Distribution

  • 10889950000899 ()
  • 10889950002008 ()

  • 4-0
PSN952S

  • Silk suture
3-0 BLACK SILK SUTURE 27", T-28 NEEDLE 17.5MM, 1/2 CIRCLE TAPER POINT
HU-FRIEDY MFG. CO., LLC
PSN872S
In Commercial Distribution

  • 10889950000875 ()
  • 10889950001988 ()

  • 3-0
PSN872S

  • Silk suture
4-0 BLACK SILK SUTURE 27", T-28 NEEDLE 17.5MM, 1/2 CIRCLE TAPER POINT
HU-FRIEDY MFG. CO., LLC
PSN871S
In Commercial Distribution

  • 10889950000868 ()
  • 10889950001971 ()

  • 4-0
PSN871S

  • Silk suture
3-0 BLACK SILK SUTURE 18", C-6 NEEDLE 18.7MM, 3/8 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN7772S
In Commercial Distribution

  • 10889950000707 ()
  • 10889950001810 ()

  • 3-0
PSN7772S

  • Silk suture
5-0 BLACK SILK SUTURE 18", C-43 NEEDLE 16.2MM, 1/2 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN7764S
In Commercial Distribution

  • 10889950000684 ()
  • 10889950001797 ()

  • 5-0
PSN7764S

  • Silk suture
3-0 BLACK SILK SUTURE 18", C-43 NEEDLE 16.2MM, 1/2 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN7762S
In Commercial Distribution

  • 10889950000660 ()
  • 10889950001773 ()

  • 3-0
PSN7762S

  • Silk suture
2-0 BLACK SILK SUTURE 18", C-9 NEEDLE 23MM, 1/2 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN737S
In Commercial Distribution

  • 10889950000646 ()
  • 10889950001759 ()

  • 2-0
PSN737S

  • Silk suture
4-0 BLACK SILK SUTURE 18", C-19 NEEDLE 18.3MM, 1/2 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN734S
In Commercial Distribution

  • 10889950000622 ()
  • 10889950001735 ()

  • 4-0
PSN734S

  • Silk suture
4-0 BLACK SILK SUTURE 27", T-4 NEEDLE 22.2MM, 1/2 CIRCLE TAPER POINT
HU-FRIEDY MFG. CO., LLC
PSN7342S
In Commercial Distribution

  • 10889950000608 ()
  • 10889950001711 ()

  • 4-0
PSN7342S

  • Silk suture
5-0 BLACK NYLON SUTURE 18", C-3 NEEDLE 13MM, 3/8 CIRCLE PREMIUM REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN698N
In Commercial Distribution

  • 10889950000547 ()
  • 10889950001650 ()

  • 5-0
PSN698N

  • Nylon suture, non-bioabsorbable, monofilament
3-0 BLACK SILK SUTURE 18", C-7 NEEDLE 24.3MM, 3/8 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN684S
In Commercial Distribution

  • 10889950000509 ()
  • 10889950001612 ()

  • 3-0
PSN684S

  • Silk suture
5-0 BLACK SILK SUTURE 18", C-6 NEEDLE 18.7MM, 3/8 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN682S
In Commercial Distribution

  • 10889950000486 ()
  • 10889950001599 ()

  • 5-0
PSN682S

  • Silk suture
4-0 BLACK NYLON SUTURE 18", C-6 NEEDLE 18.7MM, 3/8 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN662N
In Commercial Distribution

  • 10889950000462 ()
  • 10889950001575 ()

  • 4-0
PSN662N

  • Nylon suture, non-bioabsorbable, monofilament
4-0 BLACK SILK SUTURE 18", C-3 NEEDLE 13MM, 3/8 CIRCLE PREMIUM REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN641S
In Commercial Distribution

  • 10889950000448 ()
  • 10889950001551 ()

  • 4-0
PSN641S

  • Silk suture
3-0 BLACK SILK SUTURE 18", C-9 NEEDLE 23MM, 1/2 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN632S
In Commercial Distribution

  • 10889950000394 ()
  • 10889950001506 ()
  • 10889950001049 ()

  • 3-0
PSN632S

  • Silk suture
4-0 BLACK SILK SUTURE 18", C-9 NEEDLE 23MM, 1/2 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN631S
In Commercial Distribution

  • 10889950000387 ()
  • 10889950001490 ()
PSN631S

  • Silk suture
5-0 BLACK SILK SUTURE 18", C-22 NEEDLE 16.2MM, 3/8 CIRCLE REVERSE CUT
HU-FRIEDY MFG. CO., LLC
PSN1628S
In Commercial Distribution

  • 10889950000011 ()
  • 10889950001124 ()

  • 5-0
PSN1628S

  • Silk suture
The Thermo-Electric Cooling (TEC) lid Module is used in conjunction with the CardioQuip Modular Cooler-Heater (MCH) to provide cooling to slow the melting of ice in the tank. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-11TEC
In Commercial Distribution

  • 00860000846134 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Refrigeration Module is a module of the CardioQuip Modular Cooler-Heater (MCH) which creates an ice block in the tank in order to lower the temperature of the water. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-10RMS
In Commercial Distribution

  • 00860000846127 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-1000(m)
In Commercial Distribution

  • 00860000846110 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers, and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-1000(i)
In Commercial Distribution

  • 00860000846103 ()


  • Cardiopulmonary bypass system heating/cooling unit
GuideBlade, non-sterile, intended for inclusion in kits
Ambitus Medical Supplies LLC
AMB 1811
Not in Commercial Distribution

  • 20860000561918 ()
  • 00860000561914 ()
AMB 1811

  • Scalpel, single-use
Sterile GuideBlade
Ambitus Medical Supplies LLC
AMB 1746
In Commercial Distribution

  • 00860000561907 ()
  • 10860000561904 ()
  • 20860000561901 ()
  • 30860000561908 ()
AMB 1746-10

  • Scalpel, single-use
ClearPath Disposable Introducer
Clearmind Biomedical Inc.
AK-19-110
In Commercial Distribution

  • 00860000321341 ()
  • 00860000321334 ()
  • 00860000321358 ()


  • Intracerebral trocar blade
Reusable Vaginal Speculum
CEEK WOMEN'S HEALTH
NU001
In Commercial Distribution

  • 10860000270424 ()
  • 00860000270427 ()


  • Vaginal speculum, reusable
Single-Use Retraction Sheath
CEEK WOMEN'S HEALTH
VS000
In Commercial Distribution

  • 00860000270403 ()
  • 10860000270400 ()


  • Vaginal speculum, single-use
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