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The Access Hybritech p2PSA Calibrators are intended to calibrate the Access Hybritech p2PSA assay as an aid in distinguishing prostate cancer from benign prostatic conditions using human serum on the Access Immunoassay Systems.
Beckman Coulter, Inc.
B03705
In Commercial Distribution
- H628B037051 ()
B03705
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
The Access Hybritech PSA Calibrators are intended to calibrate the Access Hybritech PSA assay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
37205
In Commercial Distribution
- H628372051 ()
37205
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure.
Pramand LLC
CS-2055
In Commercial Distribution
- 00860010683712 ()
- 00860010683705 ()
- Total Volume: 5 Milliliter
CS-2055
- Dura mater sealant
The NovaSure®Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
815012US
In Commercial Distribution
- 25420045505398 ()
- 15420045505391 ()
815012US
- Radio-frequency endometrial-ablation system generator
The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
2013
In Commercial Distribution
- 15420045501126 ()
- 35420045501120 ()
- 25420045501123 ()
- 45420045501127 ()
NS2013KITUS
- Radio-frequency endometrial-ablation system handpiece/electrode
The NovaSure®Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
NovaSure Controller
In Commercial Distribution
- 15420045500860 ()
RFC2010-115
- Radio-frequency endometrial-ablation system generator
The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
NS2000US
In Commercial Distribution
- 15420045501140 ()
- 25420045501147 ()
- 35420045501144 ()
NS2000US
- Radio-frequency endometrial-ablation system handpiece/electrode
The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
2007
In Commercial Distribution
- 15420045501133 ()
- 25420045501130 ()
- 35420045501137 ()
- 45420045501134 ()
NS2007US
- Radio-frequency endometrial-ablation system handpiece/electrode
The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
NS2013US
In Commercial Distribution
- 15420045501119 ()
- 25420045501116 ()
- 35420045501113 ()
- 45420045501110 ()
NS2013US
- Radio-frequency endometrial-ablation system handpiece/electrode
The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
V5
In Commercial Distribution
- 15420045514300 ()
- 25420045514307 ()
- 35420045514304 ()
NSV5KITUS-001
- Radio-frequency endometrial-ablation system handpiece/electrode