Identity
- Trade Name
- ECHO PS FDA UDI
- Generic Name
- Surgical mesh laparoscopic delivery/positioning device FDA UDI
- Device Name
- Echo PS Positioning System Inflation Assembly FDA UDI
- Model / Reference
- 5955000 FDA UDI
- Description
- Echo PS Positioning System Inflation Assembly FDA UDI
Identifiers
- Catalog Number
- 5955000 FDA UDI
- Primary DI / UDI-DI
- 00801741077715 FDA UDI
- FDA Product Code
- OQL FDA UDIFTL FDA UDIGCJ FDA UDI
- GMDN Term
- Surgical mesh laparoscopic delivery/positioning device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI876.1500 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Echo Ps by Davol Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Davol Inc.
Sources (1)
- FDA UDI de03353a-b5a8-49eb-b2fe-4ab2b3207f4e 36 fields · synced May 30, 2026