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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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Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CD3357-40Q
In Commercial Distribution

  • 05414734508216 ()

  • Total Volume: 36 Milliliter
CD3357-40Q

  • Cardiac resynchronization therapy implantable defibrillator
Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. RADIESSE injectable implant is also indicated for hand augmentation to correct volume loss in the dorsum of the hands.
MERZ NORTH AMERICA, INC.
8071C0K1
In Commercial Distribution

  • M2138071C0K15 ()

  • Total Volume: 1.5 Milliliter


  • Dermal tissue reconstructive material, synthetic mineral
The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the anterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator.
Reshape Lifesciences Inc.
2200A-47E
Not in Commercial Distribution

  • 00857334004286 ()

  • Length: 47 Centimeter
2200A-47E

  • Vagus nerve electrical stimulation system lead
Can be used in place of Cardiac Science™ electrodes part # 9131-001. Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. Heart Sync T100-CS AED pads are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The T100-CS AED pads are used on patients over 8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8 hours)
HEART SYNC INC
T100-CS
In Commercial Distribution

  • 00868866000004 ()
  • 10868866000001 ()
T100-CS

  • Electrode conductive skin pad, single-use
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Beckman Coulter, Inc.
37200
In Commercial Distribution

  • H628372001 ()
37200

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Beckman Coulter, Inc.
C22845
In Commercial Distribution

  • 15099590701673 ()
C22845

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
RESTYLANE LYFT with Lidocaine is a sterile, biodegradable, transparent gel of stabilized hyaluronic acid of non-animal origin with the additon of lidocaine hydrochloride 0.3%. It is indicated in patients over the age of 21 for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds; for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies; and for injection into the subcutaneous plane in the dorsal hand to correct volume deficit.
SAIMA GLOBAL FARMA S.L.
Gel 1 mL Syringe
In Commercial Distribution

  • 08437027710087 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
LOADING SYS LS-ENVEOR-34-US COMM
MEDTRONIC COREVALVE LLC
LS-ENVEOR-34-US
In Commercial Distribution

  • 00643169640344 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
DELIV SYS ENVEOR-N-US 34MM COMM
MEDTRONIC COREVALVE LLC
ENVEOR-N-US
In Commercial Distribution

  • 00643169640337 ()

  • Outer Diameter: 6.7 Millimeter
  • Length: 107.0 Centimeter


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 33 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1804500-33
In Commercial Distribution

  • 08717648233678 ()

  • Stent Diameter: 5 Millimeter
  • Stent Length: 33 Millimeter
1804500-33

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
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