Identity
- Trade Name
- Drill 7mm with Entrance EUDAMEDOPRA Implant System FDA UDI
- Generic Name
- Internal-external leg prosthesis osseointegration bar FDA UDI
- Device Name
- OPRA Implant System Instruments - Non-Invasive Single Use Surgical Instruments EUDAMEDDrill 7mm with Entrance FDA UDI
- Model / Reference
- 1308 EUDAMEDFDA UDI
- Description
- Drill 7mm with Entrance FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340152101440 EUDAMEDFDA UDI
- Basic UDI-DI
- 73401521SUNIinstrumentsU9 EUDAMED
- PMA Number
- P190009 FDA UDI
- FDA Product Code
- PJY FDA UDI
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Internal-external leg prosthesis osseointegration bar FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Cranial bur, single-use
Drill 7mm with Entrance by Integrum AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cranial bur, single-use.
- HiCUT Burs — adeor Medical AG · Class II
- Disposable Sterile Vessel Punch — Zibo MK Medical Technology Co., Ltd. · Class IIa
- PDS-2RDUL-15 — NAKANISHI INC. · Class IIa
- GT PODO 7 mm spitz/pointed Schaft 2, 35 X 40 — LUKAS-ERZETT GmbH & Co.KG · Class I
- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- J-Notch Burs — Stryker Instruments · Class IIa
- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- GT PODO 5 mm rund/round Schaft 2, 35 x 35 — LUKAS-ERZETT GmbH & Co.KG · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73401521SUNIinstrumentsU9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integrum AB
- EUDAMED SRN
- SE-MF-000026900
Sources (2)
- EUDAMED a6f50bb1-3269-4404-ac4d-1698563cc0a3 61 fields · synced Jul 12, 2026
- FDA UDI 54540945-0620-4934-84ae-345c4ae755e6 35 fields · synced May 30, 2026