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US-MF-000004159gRod Bender, In Situ, 13", Angled, Ø5.5mm, Left 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 Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 26, 2026
08403142HOLDINGDAPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00840314270238
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 13 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Bulgaria | — | Still on market |
| Czechia | — | Still on market |
| Denmark | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | 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.
00840314270238Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
08403142HOLDINGDAgS 82.7717UDI 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.
L99SURGICAL INSTRUMENTS, REUSABLE - OTHERNo certificate specifically references this device's Basic UDI-DI.
08403142CUTTINGKBOn 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, Right08403142HOLDINGDAOn the marketHeath Mallet 7 1/4", 2lb [906g], head s/s Ø 45mm, alum hdl08403142IMPACTINGZVOn the marketNail Rasp #93 DE 6 3/4" 2mm angled up/down08403142SCRAPINGPDOn 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.