- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Oct 23, 2023
B-B961DP78614500BONE CHISELS AND GOUGES 85MM 16MM CHISEL BLADES, INTERCHANGEABLE is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by Daddy D Pro. Placed on the EU market in Portugal. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
PK-MF-000035172No 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.B961DP78614500
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
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 Portugal; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| PortugalPrimary placement | — | Still on market |
| Germany | — | Still on market |
| Spain | — | Still on market |
| Poland | — | 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.
B961DP78614500Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-B961DP78614500DP-786-14-50 UDI 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.
C01901999SYSTEMS FOR VESSEL EXTRACTION AND VEIN CLOSURE - 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 →No certificate specifically references this device's Basic UDI-DI.
B-B961DP78614680On the marketBONE CHISELS AND GOUGES 185MMB-B961DP78614510On the marketBONE CHISELS AND GOUGES 85MM 10MM CHISEL BLADES, INTERCHANGEABLEB-B961DP78614490On the marketBONE CHISELS AND GOUGES 85MM 16MM OSTEOTOME BLADES, INTERCHANGEABLEB-B961DP78614550On the marketBONE CHISELS AND GOUGES 85MM 25MM OSTEOTOME BLADES, INTERCHANGEABLEB-B961DP78614560On the marketBONE CHISELS AND GOUGES 85MM 5MM OSTEOTOME BLADES, INTERCHANGEABLEB-B961DP78614530On the market