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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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Wall-mounted post-treatment for water purification for dialysis applications. Includes one .03 30" filter, particulate filter, DI header, one pump, and divert-to-drain. 208V.
BETTER WATER, LLC
WM-PST-303-RM-1GJ
In Commercial Distribution

  • PS0152 ()
WM-PST-303-RM-1GJ

  • Combination water purification system
Permanent Scleral Reinforcement Matrix. Two shapes (one rectangular, one shield-shaped) are provided in each unit, to be selected according to physician preference.
CORNEAT VISION LTD
1044002
In Commercial Distribution

  • G16010440021 ()
  • G16010440020 ()
1044002

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Y-Knot RC with Tape All-Suture Anchor, with one 2 mm Hi-Fi® Tape (Blue) and one #2 (5 metric) Hi-Fi Suture (Blue)
Conmed Corporation
YRC02STC
In Commercial Distribution

  • 10845854044742 ()

  • Length: 2 Millimeter
YRC02STC

  • Tendon/ligament bone anchor, non-bioabsorbable
Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Minilap Applicator and one pair of Filshie® Clips.
FEMCARE LIMITED
AVM-951M
In Commercial Distribution

  • 15055515602197 ()
  • 45055515602358 ()
  • 15055515602357 ()
AVM-951M

  • Fallopian tube clip/band
Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Minilap Applicator and one pair of Filshie® Clips.
FEMCARE LIMITED
AVM-951M
Not in Commercial Distribution

  • 25055515602194 ()
  • 15055515602197 ()
AVM-951M

  • Fallopian tube clip/band
Carton contents (4 dose trays, 1 package insert with attached Medication Guide and mixing date stickers) are intended to be dispensed as a unit. Each dose tray contains one 25 mg vial of etanercept, one diluent syringe (1 mL Sterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27 gauge 1/2 inch needle, one vial adapter, and one plunger.
AMGEN INC.
642534
In Commercial Distribution

  • 10358406425345 ()
  • 00358406425348 ()

  • Length: 0.5 Inch
  • Needle Gauge: 27 Gauge


  • Medication transfer set
AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber Non-Pyrogenic fluid pathway. GRAVITY FEED ONLY. One Split Septum Injection Site. One Rotating Male Luer Lock Adapter. One Needleless Injection Site
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411004036 ()
  • 10704411004035 ()
D38301

  • Basic intravenous administration set, noninvasive
laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers.
Biolase, Inc.
laserwhite20
In Commercial Distribution

  • 00647529000113 ()
  • 00647529000281 ()
7400030

  • Dental coating, tooth-desensitizing
FPPL Target DPS +/- (ER)
TARGET CORPORATION
One Step Pregnancy Test
Not in Commercial Distribution

  • 00492450302887 ()
  • 00633472000133 ()
  • 10492450302884 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
FPPL Shopko DPS +/-
SPD SWISS PRECISION DIAGNOSTICS GMBH
One Step Pregnancy Test
Not in Commercial Distribution

  • 00400103056704 ()
  • 10400103056701 ()
  • 00633472000133 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
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