Identity
- Trade Name
- Jada™ System FDA UDI
- Generic Name
- Intrauterine haemostatic suction catheter FDA UDI
- Device Name
- Jada™ System Vacuum-induced Hemorrhage Control System FDA UDI
- Model / Reference
- JADA-1001 FDA UDI
- Description
- Jada™ System Vacuum-induced Hemorrhage Control System FDA UDI
Identifiers
- Catalog Number
- JADA-1001 FDA UDI
- Primary DI / UDI-DI
- 00850017882003 FDA UDI
- 510(k) Number
- K201199 FDA UDI
- FDA Product Code
- OQY FDA UDI
- GMDN Term
- Intrauterine haemostatic suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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: Intrauterine haemostatic suction catheter
Jada™ System by Alydia Health — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intrauterine haemostatic suction catheter.
- Comfort Plus Curette — Koros USA, Inc. · Class I
- Comfort Plus Curette — Koros USA, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alydia Health
Sources (1)
- FDA UDI 67159057-9925-4655-9709-241b1647efb1 37 fields · synced May 30, 2026