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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U DRAPE, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426052139 ()
  • 00748426052134 ()


  • Patient surgical drape, single-use, non-sterile
U BAR PACK
Cardinal Health 200, LLC
SBA56UBFS9
In Commercial Distribution

  • 50195594816122 ()
  • 10195594816124 ()
SBA56UBFS9

  • General surgical procedure kit, non-medicated, single-use
U BAR PACK
Cardinal Health 200, LLC
SBA40UBRD5
In Commercial Distribution

  • 50195594719294 ()
  • 10195594719296 ()
SBA40UBRD5

  • General surgical procedure kit, medicated
Super Low (U)
KURARAY NORITAKE DENTAL INC.
#4620-KA
In Commercial Distribution

  • EKUR004620KA1 ()


  • Dental composite resin
PLT Trial (U)
KURARAY NORITAKE DENTAL INC.
#3198-KA
In Commercial Distribution

  • EKUR003191KA0 ()
  • EKUR003198KA1 ()


  • Dental composite resin
Syringe Trial (U)
KURARAY NORITAKE DENTAL INC.
#3188-KA
In Commercial Distribution

  • EKUR003188KA1 ()


  • Dental composite resin
StrongArm Retail Starter Kit This kit contains: 2 each of BM001-BL, BM001-PR, BM001, BM002, BM004, & BM005
SUNSET HEALTHCARE SOLUTIONS, INC.
BM006
In Commercial Distribution

  • 00848530106133 ()


  • Single-side-support walking frame
BM001 StrongArm Comfort Cane This pack contains: (1) BM001, (1) BM001-TI, (1) BM001-BL
SUNSET HEALTHCARE SOLUTIONS, INC.
BM001-3MC
In Commercial Distribution

  • 00848530098728 ()


  • Single-side-support walking frame
Carbon Fiber Quad Cane Black
VIVE HEALTH LLC
MOB1023BLK
In Commercial Distribution

  • 10818323027317 ()
  • 00818323027310 ()


  • Single-side-support walking frame
Probasics Offset Folding Cane with Strap (Black)
COMPASS HEALTH BRANDS CORP.
CNFBK
In Commercial Distribution

  • 30815067071242 ()
  • 00815067071241 ()


  • Single-side-support walking frame
Heavy Duty Quad Cane, Large Base, Black
COMPASS HEALTH BRANDS CORP.
CNQHLBB
In Commercial Distribution

  • 30815067071235 ()
  • 00815067071234 ()


  • Single-side-support walking frame
Heavy Duty Quad Cane, Small Base Black
COMPASS HEALTH BRANDS CORP.
CNQHSBB
In Commercial Distribution

  • 30815067071228 ()
  • 00815067071227 ()


  • Single-side-support walking frame
ProBasics Large Base Quad Cane
COMPASS HEALTH BRANDS CORP.
CNQLB
In Commercial Distribution

  • 30815067071198 ()
  • 00815067071197 ()


  • Single-side-support walking frame
ProBasics Small Base Quad Cane
COMPASS HEALTH BRANDS CORP.
CNQSB
In Commercial Distribution

  • 30815067071181 ()
  • 00815067071180 ()


  • Single-side-support walking frame
ProBasics Bariatric Offset Cane with Wrist Strap (Black)
COMPASS HEALTH BRANDS CORP.
CNOFHD
In Commercial Distribution

  • 30815067071174 ()
  • 00815067071173 ()


  • Single-side-support walking frame
ProBasics Offset Cane with Wrist Strap (Black)
COMPASS HEALTH BRANDS CORP.
CNOFBK
In Commercial Distribution

  • 30815067071136 ()
  • 00815067071135 ()


  • Single-side-support walking frame
LME ROTH 018 U/L 5-5 UK U 3
Gc Orthodontics America Inc.
32-1CC3-9005
In Commercial Distribution

  • D788321CC390051 ()
32-1CC3-9005

  • Orthodontic bracket, metal
Biowave Noninvasive Electrode - U-Set
BIOWAVE CORPORATION
MK78580 - BWEN03-U
In Commercial Distribution

  • 20859911006106 ()
  • 10859911006109 ()
  • 00859911006102 ()


  • Transcutaneous electrical stimulation electrode, single-use
1, Needle App 18ga x 20cm Brachytherapy Non-Waxed, St
STELLAR MEDICAL, LLC
NA-1820SQ-NWS
In Commercial Distribution

  • 00853162006416 ()


  • Radiological image marker, implantable
  • Brachytherapy injection needle
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
US Dexcom Follow App for iOS, (mg/dL), v4
Dexcom, Inc.
SW10497
In Commercial Distribution

  • 00386270001931 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
US Dexcom Follow App for Android (mg/dL), v4
Dexcom, Inc.
SW10583
In Commercial Distribution

  • 00386270001917 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
DreamMapper Mobile App Android, Asia- Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054240 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android, North America Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054226 ()
1101479

  • Self-care monitoring/reporting software
WAG Premium Arm GEN5 No Qualcomm/Homedics BT App
WALGREEN CO.
897652
In Commercial Distribution

  • 00311917206974 ()
  • 10311917206971 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Pressure PreventionBlank Product Description: Balanced Aire APP Mattress Custom
Drive Devilbiss Healthcare
BA9600-CUSTOM
In Commercial Distribution

  • 00822383577173 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush
Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush
SPRAY SET ENDOSCOPIC APP. 5MMX40 CM, 11:1 RATIO
Micromedics, Inc.
SA-3658
In Commercial Distribution

  • 00815634020191 ()
  • 10815634020198 ()
  • 20815634020195 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
SPRAY SET ENDOSCOPIC APP. 5MMX30 CM, 11:1 RATIO
Micromedics, Inc.
SA-3657
In Commercial Distribution

  • 00815634020177 ()
  • 10815634020174 ()
  • 20815634020171 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
Tampons, Retail, App. Reg.25/Super 10/Super+ 10
Cora
02Tampons-322
In Commercial Distribution

  • 00850373007041 ()
  • 00810042481893 ()


  • Menstrual tampon, unscented
DBD-PUMP, APP W/PAD, AERO PULSE, 31" X 6
MEDLINE INDUSTRIES, INC.
MSC80700A
In Commercial Distribution

  • 30080196669886 ()
MSC80700A

  • Alternating-pressure inflator
KIT, G U MAJOR
Cardinal Health 200, LLC
PG5AMJKSO
In Commercial Distribution

  • 50888439600849 ()
  • 10888439600841 ()
PG5AMJKSO

  • Urological surgical procedure kit, medicated, single-use
G U MAJOR PACK
Cardinal Health 200, LLC
PG5AMJKSN
In Commercial Distribution

  • 50888439395370 ()
  • 10888439395372 ()
PG5AMJKSN

  • General surgical procedure kit, medicated
DRAPE POLY U 60X80
MEDLINE INDUSTRIES, INC.
80320CS
In Commercial Distribution

  • 40080196001898 ()
  • 10080196001897 ()
80320CS

  • Patient surgical drape, single-use, non-sterile
G U MINOR PACK
Cardinal Health 200, LLC
SBA56PL19Z
In Commercial Distribution

  • 50888439461761 ()
  • 10888439461763 ()
SBA56PL19Z

  • General surgical procedure kit, non-medicated, single-use
G U MAJOR PACK
Cardinal Health 200, LLC
PG5AMJKS3
In Commercial Distribution

  • 50888439447550 ()
  • 10888439447552 ()
PG5AMJKS3

  • General surgical procedure kit, medicated
32" U Surgical Monitor
ADLINK Technology GmbH
ASM32U-PE
In Commercial Distribution

  • 04260657690320 ()
93-DM31G-10XX

  • Image display unit, colour
U Series Perforator Chuck
STRYKER CORPORATION
5100010060
Not in Commercial Distribution

  • 04546540074515 ()
5100-010-060

  • Surgical drill chuck
U/Adapt-It Straight Adapter
VYAIRE MEDICAL, INC.
004083
In Commercial Distribution

  • 50190752152593 ()
  • 10190752152595 ()
004083

  • Straight/elbow breathing circuit connector, single-use
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