Eu Mdd
Eu Md Class 1
On The Market
🇺🇸 United States
Uromedica ACT/ProACT Tissue Expanding Device II
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00180668000045
- Basic UDI-DI Code
- B-00180668000045
- Reference
- 750034
- Device Types
-
Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Uromedica, Incorporated
Additional Description
A reusable, steam sterilizable Tissue Expanding Device (TED II). This tool consists of a main shaft with handle and a removable jaw. This tool is designed to fit within the U-channel sheath of the implantation instrument set to assist in dilation of the tissue at the distal end of the U-channel sheath.
CND Nomenclature Codes
| Code | Description |
|---|---|
| L99 | SURGICAL INSTRUMENTS, REUSABLE - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | Q5 045789 0019 | TÜV SÜD Product Service GmbH | Expired |
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