- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Mar 27, 2024
081006022DRIVERRUC1L5BIO | Max IJHWT Guided Driver Variable Height is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Blue Sky Bio, LLC. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
US-MF-000014016No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.(01)00810060224823
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Apr 21, 2022 | Still on market |
| Austria | — | Still on market |
| EL | — | Still on market |
| France | — | Still on market |
| Ireland | — | Still on market |
| Italy | — | Still on market |
| Portugal | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00810060224823Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
081006022DRIVERRUC1L5DTGJHWTVRUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q010399SURGICAL DENTAL DEVICES - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →081006022IMTRANSUC1NPOn the marketBIO | Max Driver 8.5mm Hex NP081006022DRIVERRUC1L5On the marketBIO | Max Driver Variable Height NP081006022DRIVERRUC1L5On the marketBIO | Max Implant Analog NP081513102ANALOGSUC19NOn the marketBIO | Max Implant Analog RP081513102ANALOGSUC19NOn the marketBIO | Max Implant Driver Handpiece NP Long081513102DRIVERRUC1QTOn the marketNo certificate specifically references this device's Basic UDI-DI.