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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Perio diamond instrument, fine
DFS - DIAMON GmbH
540016
In Commercial Distribution

  • 04057176134141 ()
  • 04057176134158 ()


  • Diamond dental bur, reusable
Perio diamond instrument, med.
DFS - DIAMON GmbH
540028
In Commercial Distribution

  • 04057176134127 ()
  • 04057176134134 ()


  • Diamond dental bur, reusable
Perio diamond instrument, fine
DFS - DIAMON GmbH
540026
In Commercial Distribution

  • 04057176134103 ()
  • 04057176134110 ()


  • Diamond dental bur, reusable
Perio diamond instrument, med.
DFS - DIAMON GmbH
540038
In Commercial Distribution

  • 04057176134080 ()
  • 04057176134097 ()


  • Diamond dental bur, reusable
Perio diamond instrument, fine
DFS - DIAMON GmbH
540036
In Commercial Distribution

  • 04057176134066 ()
  • 04057176134073 ()


  • Diamond dental bur, reusable
Perio diamond instrument, superfine
DFS - DIAMON GmbH
540034
In Commercial Distribution

  • 04057176134042 ()
  • 04057176134059 ()


  • Diamond dental bur, reusable
Perio diamond instrument, superfine
DFS - DIAMON GmbH
540024
In Commercial Distribution

  • 04057176134028 ()
  • 04057176134035 ()


  • Diamond dental bur, reusable
Perio diamond instrument, superfine
DFS - DIAMON GmbH
540014
In Commercial Distribution

  • 04057176134004 ()
  • 04057176134011 ()


  • Diamond dental bur, reusable
Perio diamond instrument, superfine
DFS - DIAMON GmbH
540004
In Commercial Distribution

  • 04057176133984 ()
  • 04057176133991 ()


  • Diamond dental bur, reusable
TheraBase Ca 1g Dual Syringe
BISCO INC.
H-3502S
Not in Commercial Distribution

  • D757H3502S0 ()
H-3502S

  • Dental composite resin
TheraBase Ca 1g Dual Syringe Pkg
BISCO INC.
H-3502PS
Not in Commercial Distribution

  • D757H3502PS1 ()
H-3502PS

  • Dental composite resin
TheraBase Ca 8g Dual Syringe Pkg
BISCO INC.
H-35010P
Not in Commercial Distribution

  • D757H35010P1 ()
H-35010P

  • Dental composite resin
TheraBase Ca 8g Dual Syringe
BISCO INC.
H-3501
Not in Commercial Distribution

  • D757H35010 ()
H-3501

  • Dental composite resin
THERACEM Ca 1G DUAL SYR SAMPLE
BISCO INC.
D-46502S
Not in Commercial Distribution

  • D757D46502S0 ()
D-46502S

  • Dental composite resin
THERACEM Ca 1g DUAL SYR SMPL PKG
BISCO INC.
D-46502PS
Not in Commercial Distribution

  • D757D46502PS0 ()
D-46502PS

  • Dental composite resin
THERACEM Ca 8g REFILL PACKAGE
BISCO INC.
D-46501P
Not in Commercial Distribution

  • D757D46501P1 ()
D-46501P

  • Dental composite resin
THERACEM Ca 8g DUAL SYRINGE
BISCO INC.
D-46501
Not in Commercial Distribution

  • D757D465010 ()
D-46501

  • Dental composite resin
No Description
B& L Biotech, inc.
CAN120
In Commercial Distribution

  • 08800019151449 ()


  • Dental ultrasonic surgical system handpiece tip
No Description
B& L Biotech, inc.
CAN90
In Commercial Distribution

  • 08800019151432 ()


  • Dental ultrasonic surgical system handpiece tip
No Description
B& L Biotech, inc.
CA120-E
In Commercial Distribution

  • 08800019151425 ()


  • Dental ultrasonic surgical system handpiece tip
No Description
B& L Biotech, inc.
CA90-E
In Commercial Distribution

  • 08800019151418 ()


  • Dental ultrasonic surgical system handpiece tip
No Description
B& L Biotech, inc.
CA120-A
In Commercial Distribution

  • 08800019151401 ()


  • Dental ultrasonic surgical system handpiece tip
No Description
B& L Biotech, inc.
CA90-A
In Commercial Distribution

  • 08800019151395 ()


  • Dental ultrasonic surgical system handpiece tip
Awl, With Stop
Life Spine, Inc.
116-234
In Commercial Distribution

  • 00190837091071 ()
116-234

  • Bone awl, single-use
Hexalobe T-25 Driver Shaft, 1/4", Cannulated
Life Spine, Inc.
148-398
In Commercial Distribution

  • 00190837087210 ()
148-398

  • Surgical screwdriver, reusable
No Description
BIOCARE MEDICAL LLC
CM123A
In Commercial Distribution

  • 00847627006257 ()


  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM123AA
In Commercial Distribution

  • 00847627011077 ()


  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM101AA
In Commercial Distribution

  • 00847627010988 ()


  • Cancer antigen 125 (CA125) IVD, antibody
No Description
BIOCARE MEDICAL LLC
AVI123G
In Commercial Distribution

  • 00847627031662 ()


  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody
SPECIALTY TRIAL SET
Stryker Corporation
IS2059REL
In Commercial Distribution

  • 07613327278729 ()

  • Height: 10.0 Millimeter
  • Angle: 5.0 degree
  • Length: 11.0 Millimeter
  • Width: 14.0 Millimeter
IS2059REL

  • General internal orthopaedic fixation system implantation kit
TheraBase Ca 1g Dual Syringe Pkg
BISCO INC.
H-3502PS
In Commercial Distribution

H-3502PS

  • Dental composite resin
TheraBase Ca 1g Dual Syringe
BISCO INC.
H-3502S
In Commercial Distribution

H-3502S

  • Dental composite resin
TheraBase Ca 8g Dual Syringe Pkg
BISCO INC.
H-35010P
In Commercial Distribution

H-35010P

  • Dental composite resin
TheraBase Ca 8g Dual Syringe
BISCO INC.
H-3501
In Commercial Distribution

H-3501

  • Dental composite resin
THERACEM Ca 1g DUAL SYR SMPL PKG
BISCO INC.
D-46502PS
In Commercial Distribution

D-46502PS

  • Dental composite resin
THERACEM Ca 1G DUAL SYR SAMPLE
BISCO INC.
D-46502S
In Commercial Distribution

D-46502S

  • Dental composite resin
THERACEM Ca 8g REFILL PACKAGE
BISCO INC.
D-46501P
In Commercial Distribution

D-46501P

  • Dental composite resin
THERACEM Ca 8g DUAL SYRINGE
BISCO INC.
D-46501
In Commercial Distribution

D-46501

  • Dental composite resin
CAREvent CA hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent CA delivers automatic ventilation with controlled flow rate, airway pressure, tidal volume and frequency. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. In addition, CAREvent ALS, CA, DRA and Genesis II allow the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume. The CAREvent CA is designed for resuscitation in toxic environments. A constant bleed flow reduces the risk of a patient drawing toxic air into the mask should a leak occur.
O-Two Medical Technologies Inc
01CV3000-CA
In Commercial Distribution

  • 07540195025202 ()
  • 07540195025196 ()

  • Weight: 0.45 Kilogram
  • Height: 2.9 Inch
  • Width: 2.5 Inch
  • Length: 5.5 Inch
01CV3000-CA

  • Pulmonary resuscitator, pneumatic, reusable
Lenke Style Curved Probe
Life Spine, Inc.
116-280
In Commercial Distribution

  • 00190837091088 ()
116-280

  • Bone-screw internal spinal fixation system, non-sterile
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