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Fixture Removal Trephine and Guide Sleeves Kit 22 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2546
by Integrum AB
Identity
- Trade Name
- Fixture Removal Trephine and Guide Sleeves Kit 22 mm EUDAMEDFixture Removal Trephine and Guide Sleeve Kit 22 mm FDA UDI
- Generic Name
- Internal-external leg prosthesis osseointegration bar FDA UDI
- Device Name
- OPRA Implant System Instruments - Invasive Single Use Surgical Instruments EUDAMEDThe fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture. The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone. FDA UDI
- Model / Reference
- 2546 EUDAMEDFDA UDI
- Description
- The fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture. The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340152101761 EUDAMEDFDA UDI
- Basic UDI-DI
- 73401521SUIinstrumentsBX 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 IIa EUDAMEDClass III FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Cranial bur, single-use
Fixture Removal Trephine and Guide Sleeves Kit 22 mm by Integrum AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cranial bur, single-use.
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- 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 | 73401521SUIinstrumentsBX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Integrum AB
- EUDAMED SRN
- SE-MF-000026900
Sources (2)
- EUDAMED 09948310-59d0-4a0f-a374-8e31187e624e 61 fields · synced Jun 19, 2026
- FDA UDI 09531cf4-4c49-4ac9-9bc7-2c8ffd39aef1 34 fields · synced May 30, 2026