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815012us

FDA UDI

Class III (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
815012US FDA UDI
Generic Name
Radio-frequency endometrial-ablation system generator FDA UDI
Device Name
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. FDA UDI
Model / Reference
815012US FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
815012US FDA UDI
Primary DI / UDI-DI
25420045505398 FDA UDI
PMA Number
P010013 FDA UDI
FDA Product Code
MNB FDA UDI
GMDN Term
Radio-frequency endometrial-ablation system generator FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radio-frequency endometrial-ablation system generator

815012us by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency endometrial-ablation system generator.

Cleared under the same submission

P010013 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI 4dcca622-4c17-45e0-8cfc-0d02ff2d8fb2 35 fields · synced Jun 8, 2026