NDC Code(s) : 59365-5128-1
Packager : CooperSurgical, Inc.
Category : HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
ParaGard T 380ACopper INTRAUTERINE DEVICE | ||||||||||||||||||||
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LABELER - CooperSurgical, Inc.(801895244) |
PRINCIPAL DISPLAY PANEL
PARAGARD
Intrauterine Copper Contraceptive
1 Unit
ParaGard® T380A Intrauterine Copper Contraceptive Single Carton Text
CooperSurgical, Inc.
95 Corporate Drive, Trumbull, CT 06611 USA
1
UNIT
PARAGARD ® T380A
intrauterine copper contraceptive
NDC 59365-5128-1
Each unit wound with approximately 176 mg of copper wire. In addition, a single copper sleeve is swaged on each of the two transverse arms. Each sleeve contains approximately 68.7 mg of copper.
The total surface area of copper on the device is 380 ± 23mm2. IMPORTANT: To be inserted in the uterus only by a licensed clinician or under the supervision of a physician. See detailed instructionsf or use.
NOTE: A Patient Package Insert is provided with each unit. Please ensure that this package insert is provided to the patient. Review patient brochure with each patient before insertion.
Store at controlled room temperature: 59° to 86°F (15° to 30°C)
CooperSurgical, Inc., 95 Corporate Drive, Trumbull, CT 06611