← Back to catalogue

Mara Water Vapor Probe Kit

FDA UDI

Class III (US FDA UDI)

by Aegea Medical Inc.

Identity

Trade Name
Mara Water Vapor Probe Kit FDA UDI
Generic Name
Water vapour endometrial-ablation applicator FDA UDI
Device Name
Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe and saline supply line with spiked end. FDA UDI
Model / Reference
DDK-16-050 FDA UDI
Description
Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe and saline supply line with spiked end. FDA UDI

Identifiers

Catalog Number
DDK-16-050 FDA UDI
Primary DI / UDI-DI
00857379006030 FDA UDI
PMA Number
P160047 FDA UDI
FDA Product Code
MNB FDA UDI
GMDN Term
Water vapour endometrial-ablation applicator FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Category: Water vapour endometrial-ablation applicator

Mara Water Vapor Probe Kit by Aegea Medical Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Water vapour endometrial-ablation applicator.

Cleared under the same submission

P160047 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aegea Medical Inc.

Sources (1)

  • FDA UDI ce9ab100-8adc-4535-8553-f82edece84c9 36 fields · synced May 30, 2026