Eu Mdd
Eu Md Class 2a
On The Market
๐บ๐ธ United States
XCEL Detachment Controller
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1
Basic Information
- Primary DI
- 00818053022579
- Basic UDI-DI Code
- B-00818053022579
- Reference
- XCEL
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- BALT USA LLC
Additional Description
The XCEL Detachment Controller is used in conjunction with the Optima Coil System and thermally detaches the coils from the pusher system. The XCEL Detachment Controller comes pre-loaded batteries and is a sterile, handheld, single-patient-use device which should not be reused, re-sterilized, opened, or tampered with. The Optima Coils and XCEL Detachment Controller(s) are sold separately. The XCEL Detachment controller is only to be used with the Optima Coil system. The Optima Coil achieves detachment by an internal heater element which is powered by the XCEL Detachment Controller.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12109099 | VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 170776241 | DQS Medizinprodukte GmbH | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).
Coiled Tubing
Device
EU MDD
·
Eu Md Class 2a
·Liebel-Flarsheim Company, LLC ·On the market·2 countries
Sterivap HP
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·9 countries
Sterivap
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·9 countries
Selectomat SL
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·2 countries
Sterivap SL
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·7 countries
Unisteri HP
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·8 countries