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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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Epic® - M595S3600

Universal B2/B3 Epic®-TmpT Composite in 3-gram Syringe
PARKELL, INC.
S360
Not in Commercial Distribution

  • M595S3600 ()
S360

  • Dental composite resin

iProven - 08719481720490

Blood Pressure Monitor with Bluetooth 10 units in one carton
Masena Invest B.V.
BPM-2244BT-10
Not in Commercial Distribution

  • 08719481720490 ()
  • 00871948172049 ()


  • Intermittent electronic patient thermometer

Good Neighbor Pharmacy - 00087701405112

Sterile Saline Wound Wash. Packaged in an aerosol (BOV) can.
Amerisourcebergen Drug Corporation
40511
In Commercial Distribution

  • 00087701405112 ()
  • 10087701405119 ()


  • Wound irrigation sterile saline

Luvena - 00899655002114

Luvena Vaginal Moisturizer & Lubricant - 6 Pre-filled Applicators in unit carton
LACLEDE, INC.
Vaginal Moisturizer & Lubricant
In Commercial Distribution

  • 00899655002114 ()


  • Sexual lubricant

BREMER - 10705034341989

BREMER Pediatric Halo System LARGE RING 17-19.5 in. (43-50 cm)
DEPUY SPINE, LLC
PT022
Not in Commercial Distribution

  • 10705034341989 ()
PT022

  • Cervical spine immobilization system, single-use

BREMER - 10705034341972

BREMER PEDIATRIC HALO SYSTEM SMALL RING 15-16 in. (38-41 cm)
DEPUY SPINE, LLC
PT021
Not in Commercial Distribution

  • 10705034341972 ()
PT021

  • Cervical spine immobilization system, single-use

BREMER HALO CROWN - 10705034341958

BREMER HALO CROWN SYSTEM LARGE CROWN 23-26 in. (58-66 cm)
DEPUY SPINE, LLC
HT036
Not in Commercial Distribution

  • 10705034341958 ()
HT036

  • Cervical spine immobilization system, single-use

BREMER HALO CROWN - 10705034341934

BREMER HALO CROWN SYSTEM SMALL CROWN 19-23 in. (48-58 cm)
DEPUY SPINE, LLC
HT035
Not in Commercial Distribution

  • 10705034341934 ()
HT035

  • Cervical spine immobilization system, single-use

Fred's Pharmacy - 00084579118625

Sterile Saline Wound Wash. Packaged in an Aerosol (BOV) can.
FRED'S, INC.
11862
In Commercial Distribution

  • 10084579118622 ()
  • 00084579118625 ()


  • Wound irrigation sterile saline

ACTEON - 03609820875521

Diamond-coated spherical tip designed particulary for osteoplasty in interproximal zones
SATELEC
TIP CE2 II
In Commercial Distribution

  • 03609820875521 ()
F87552

  • Dental ultrasonic surgical system handpiece tip
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