Identity
- Trade Name
- Exsudex disposable canister FDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- Device Name
- The Exsudex® Disposable Canister, commercially labelled as NewERA Disposable Canister, has the following features and is only to be used together with the NewERA II wound drainage system: - Canister capacity 300 cc; - Bacterial filter; - Fixed non-sterile suction tube with clamb and luer-lock connector - Dissolving sachet solidifying agent FDA UDI
- Model / Reference
- NewERA II disposable canister with tube and connector FDA UDI
- Description
- The Exsudex® Disposable Canister, commercially labelled as NewERA Disposable Canister, has the following features and is only to be used together with the NewERA II wound drainage system: - Canister capacity 300 cc; - Bacterial filter; - Fixed non-sterile suction tube with clamb and luer-lock connector - Dissolving sachet solidifying agent FDA UDI
Identifiers
- Catalog Number
- 16690-NEWERA FDA UDI
- Primary DI / UDI-DI
- 08718104890091 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Surgical suction system collection container, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Exsudex disposable canister by Meditop B.V. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Meditop B.V.
Sources (1)
- FDA UDI d74f8304-fffc-4f64-aa7c-9f407bb242a6 37 fields · synced Jun 1, 2026