- Role
- Country
- Date of registration
- Address
US-MF-000004159Nail Rasp #93 DE 6 3/4" 2mm angled up/down 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 France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 26, 2026
08403142SCRAPINGPDPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00840314232205
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 France; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary 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 |
| Finland | — | 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.
00840314232205Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
08403142SCRAPINGPDgS 61.6380UDI 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.
L091201ORTHOPAEDIC SURGERY RASPS, REUSABLENo 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.08403142HOLDINGDAOn the marketgRod Bender, In Situ, 13", Angled, Ø5.5mm, Right08403142HOLDINGDAOn the marketHeath Mallet 7 1/4", 2lb [906g], head s/s Ø 45mm, alum hdl08403142IMPACTINGZVOn the marketPeriarticular Reduction Fcps 15" str large, ball tips, 39mm-181mm opening08403142HOLDINGDAOn the marketPeriarticular Reduction Fcps 15" str med, ball tips, 14mm-128mm opening08403142HOLDINGDAOn the marketPeriarticular Reduction Forceps 11" straight small, ball tips, 24mm to 115mm opening08403142HOLDINGDAOn the marketNo certificate specifically references this device's Basic UDI-DI.