- Role
- Country
- Date of registration
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US-MF-000004159gDrill Bit, 6", SQC, 3 flutes, Ø 2.5mm, max ID 1.2mm cann, 20mm is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by gSource, LLC. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 26, 2026
08403142CUTTINGKBPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00840314269898
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 Finland; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | — | Still on market |
| Bulgaria | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Hungary | — | Still on market |
| Italy | — | Still on market |
| Portugal | — | Still on market |
| Sweden | — | Still on market |
| Slovakia | — | 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.
00840314269898Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
08403142CUTTINGKBgS 86.8825UDI 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.
L1104BITS FOR NEUROSURGERY DRILLS, REUSABLENo certificate specifically references this device's Basic UDI-DI.
08403142HOLDINGDAOn the marketDrill Bit 6 1/2" SQC, 4 flutes, Ø 3.2mm, max ID 1.75mm cann, 40mm08403142CUTTINGKBOn the marketDrill Bit 6" SQC, 3 flutes, Ø 2.0mm, max ID 1.0mm cann, 20mm08403142CUTTINGKBOn the marketgElevator, Rhoton Plus, 8 1/2", Angled, with Silicone Handle, Navy Blue08403142RETRACTDISTRACTDLOn the marketgElevator, Rhoton Plus, 8 1/2", Curved, with Silicone Handle, Navy Blue08403142RETRACTDISTRACTDLOn the marketgRod Bender, In Situ, 13", Angled, Ø5.5mm, Left08403142HOLDINGDAOn the marketNo 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.