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Invotec ENT Bur
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref BC-70700PModel ENT BurRef BD-70550PRef BC-70350PRef BD-70300PRef BD-70450PRef BC-70100Ref BC-70150Ref BD-70400PRef BD-70300Ref BC-70550Ref BC-70050Ref BC-70100PRef BC-70500Ref BC-70400PRef BC-70400Ref BC-70300Ref BC-70050PRef BC-70250Ref BC-70450PRef BC-70300PRef BD-70500Ref BC-70600PRef BC-70200PRef BC-70650P
Identity
- Trade Name
- Invotec ENT Bur FDA UDI
- Generic Name
- Diamond ENT bur, single-use FDA UDIMetal/carbide ENT bur, single-use FDA UDI
- Device Name
- ENT Bur EUDAMEDDIAMOND BUR 2.5mm X 70mm PLAIN SHAFT FDA UDIDIAMOND BUR 5.5mm X 70mm PLAIN SHAFT FDA UDICARBIDE BUR 4.0mm X 70mm, FLUTES: 8 PLAIN SHAFT FDA UDICARBIDE BUR 5.5mm X 70mm, FLUTES: 10 Notched End FDA UDICARBIDE BUR 5.0mm X 70mm, FLUTES: 10 Notched End FDA UDICARBIDE BUR 1.5mm X 70mm, FLUTES: 6 Notched End FDA UDICARBIDE BUR 4.5mm X 70mm, FLUTES: 10 PLAIN SHAFT FDA UDICARBIDE BUR 4.0mm X 70mm, FLUTES: 8 Notched End FDA UDICARBIDE BUR 7.0mm X 70mm, FLUTES: 12 PLAIN SHAFT FDA UDIDIAMOND BUR 3.0mm X 70mm Notched End FDA UDICARBIDE BUR 1.0mm X 70mm, FLUTES: 6 PLAIN SHAFT FDA UDIDIAMOND BUR 5.0mm X 70mm Notched End FDA UDICARBIDE BUR 2.5mm X 70mm, FLUTES: 6 Notched End FDA UDICARBIDE BUR 0.5mm X 70mm, FLUTES: 4 Notched End FDA UDICARBIDE BUR 1.0mm X 70mm, FLUTES: 6 Notched End FDA UDIDIAMOND BUR 4.5mm X 70mm PLAIN SHAFT FDA UDICARBIDE BUR 3.5mm X 70mm, FLUTES: 8 PLAIN SHAFT FDA UDIDIAMOND BUR 4.0mm X 70mm PLAIN SHAFT FDA UDICARBIDE BUR 6.5mm X 70mm, FLUTES: 10 PLAIN SHAFT FDA UDICARBIDE BUR 3.0mm X 70mm, FLUTES: 8 Notched End FDA UDICARBIDE BUR 0.5mm X 70mm, FLUTES: 4 PLAIN SHAFT FDA UDICARBIDE BUR 6.0mm X 70mm, FLUTES: 10 PLAIN SHAFT FDA UDICARBIDE BUR 2.0mm X 70mm, FLUTES: 6 PLAIN SHAFT FDA UDICARBIDE BUR 3.0mm X 70mm, FLUTES: 8 PLAIN SHAFT FDA UDIDIAMOND BUR 3.0mm X 70mm PLAIN SHAFT FDA UDI
- Model / Reference
- BD-70550P EUDAMEDFDA UDIBC-70400P EUDAMEDFDA UDIBC-70550 EUDAMEDFDA UDIBC-70500 EUDAMEDFDA UDIBC-70150 EUDAMEDFDA UDIBC-70450P EUDAMEDFDA UDIBC-70400 EUDAMEDFDA UDIBC-70700P EUDAMEDFDA UDIBD-70300 EUDAMEDFDA UDIBC-70100P EUDAMEDFDA UDIBD-70500 EUDAMEDFDA UDIBC-70250 EUDAMEDFDA UDIBC-70050 EUDAMEDFDA UDIBC-70100 EUDAMEDFDA UDIBD-70450P EUDAMEDFDA UDIBC-70350P EUDAMEDFDA UDIBD-70400P EUDAMEDFDA UDIBC-70650P EUDAMEDFDA UDIBC-70300 EUDAMEDFDA UDIBC-70050P EUDAMEDFDA UDIBC-70600P EUDAMEDFDA UDIBC-70200P EUDAMEDFDA UDIBC-70300P EUDAMEDFDA UDIBD-70300P EUDAMEDFDA UDIENT Bur EUDAMEDBD-70250P FDA UDI
- Description
- DIAMOND BUR 2.5mm X 70mm PLAIN SHAFT FDA UDIDIAMOND BUR 5.5mm X 70mm PLAIN SHAFT FDA UDICARBIDE BUR 4.0mm X 70mm, FLUTES: 8 PLAIN SHAFT FDA UDICARBIDE BUR 5.5mm X 70mm, FLUTES: 10 Notched End FDA UDICARBIDE BUR 5.0mm X 70mm, FLUTES: 10 Notched End FDA UDICARBIDE BUR 1.5mm X 70mm, FLUTES: 6 Notched End FDA UDICARBIDE BUR 4.5mm X 70mm, FLUTES: 10 PLAIN SHAFT FDA UDICARBIDE BUR 4.0mm X 70mm, FLUTES: 8 Notched End FDA UDICARBIDE BUR 7.0mm X 70mm, FLUTES: 12 PLAIN SHAFT FDA UDIDIAMOND BUR 3.0mm X 70mm Notched End FDA UDICARBIDE BUR 1.0mm X 70mm, FLUTES: 6 PLAIN SHAFT FDA UDIDIAMOND BUR 5.0mm X 70mm Notched End FDA UDICARBIDE BUR 2.5mm X 70mm, FLUTES: 6 Notched End FDA UDICARBIDE BUR 0.5mm X 70mm, FLUTES: 4 Notched End FDA UDICARBIDE BUR 1.0mm X 70mm, FLUTES: 6 Notched End FDA UDIDIAMOND BUR 4.5mm X 70mm PLAIN SHAFT FDA UDICARBIDE BUR 3.5mm X 70mm, FLUTES: 8 PLAIN SHAFT FDA UDIDIAMOND BUR 4.0mm X 70mm PLAIN SHAFT FDA UDICARBIDE BUR 6.5mm X 70mm, FLUTES: 10 PLAIN SHAFT FDA UDICARBIDE BUR 3.0mm X 70mm, FLUTES: 8 Notched End FDA UDICARBIDE BUR 0.5mm X 70mm, FLUTES: 4 PLAIN SHAFT FDA UDICARBIDE BUR 6.0mm X 70mm, FLUTES: 10 PLAIN SHAFT FDA UDICARBIDE BUR 2.0mm X 70mm, FLUTES: 6 PLAIN SHAFT FDA UDICARBIDE BUR 3.0mm X 70mm, FLUTES: 8 PLAIN SHAFT FDA UDIDIAMOND BUR 3.0mm X 70mm PLAIN SHAFT FDA UDI
Identifiers
- Catalog Number
- BD-70250P FDA UDIBD-70550P FDA UDIBC-70400P FDA UDIBC-70550 FDA UDIBC-70500 FDA UDIBC-70150 FDA UDIBC-70450P FDA UDIBC-70400 FDA UDIBC-70700P FDA UDIBD-70300 FDA UDIBC-70100P FDA UDIBD-70500 FDA UDIBC-70250 FDA UDIBC-70100 FDA UDIBD-70450P FDA UDIBC-70350P FDA UDIBD-70400P FDA UDIBC-70650P FDA UDIBC-70300 FDA UDIBC-70050P FDA UDIBC-70600P FDA UDIBC-70200P FDA UDIBC-70300P FDA UDIBD-70300P FDA UDI
- Primary DI / UDI-DI
- 00818501021772 EUDAMEDFDA UDI00818501021871 EUDAMEDFDA UDI00818501021499 EUDAMEDFDA UDI00818501021543 EUDAMEDFDA UDI00818501021529 EUDAMEDFDA UDI00818501021383 EUDAMEDFDA UDI00818501021512 EUDAMEDFDA UDI00818501021482 EUDAMEDFDA UDI00818501021611 EUDAMEDFDA UDI00818501021376 EUDAMEDFDA UDI00818501021857 EUDAMEDFDA UDI00818501021420 EUDAMEDFDA UDI00818501021345 EUDAMEDFDA UDI00818501021369 EUDAMEDFDA UDI00818501021840 EUDAMEDFDA UDI00818501021475 EUDAMEDFDA UDI00818501021833 EUDAMEDFDA UDI00818501021598 EUDAMEDFDA UDI00818501021444 EUDAMEDFDA UDI00818501021352 EUDAMEDFDA UDI00818501021574 EUDAMEDFDA UDI00818501021413 EUDAMEDFDA UDI00818501021451 EUDAMEDFDA UDI00818501021796 EUDAMEDFDA UDI00818501021789 FDA UDI
- Basic UDI-DI
- 081850102ENTBursN5 EUDAMED
- FDA Product Code
- EQJ FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Diamond ENT bur, single-use FDA UDIMetal/carbide ENT bur, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.4140 FDA UDI
- Market of Registration
- Austria 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 UDIFDA 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diamond ENT bur, single-use
Invotec ENT Bur by Invotec International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Diamond ENT bur, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
Sources (49)
- FDA UDI 0e824c9a-35ba-486f-a4c6-737740d94837 34 fields · synced Sep 17, 2026
- FDA UDI 328239ac-5833-416e-9c78-5ba272598583 34 fields · synced May 25, 2026
- FDA UDI fadc95f7-0471-4c51-be42-d1b397e5a9ba 34 fields · synced May 26, 2026
- FDA UDI 2a6d7ff3-8a2b-4b34-a481-ef714ae133e8 34 fields · synced May 29, 2026
- FDA UDI a2b119fb-f4ea-42d3-989c-be3e9afa587a 34 fields · synced May 29, 2026
- FDA UDI 13d6baaf-3f56-4b45-9716-fc43e20117e4 34 fields · synced May 30, 2026
- FDA UDI 992c7c32-2721-4d8e-bcda-a3f4f443e5e7 34 fields · synced May 30, 2026
- FDA UDI ba1f240b-f904-4134-9899-76be5fe92406 34 fields · synced May 30, 2026
- FDA UDI a42a1cb6-0918-4700-aa4b-e84011d3ce11 34 fields · synced May 30, 2026
- FDA UDI 009f4127-2c62-45ee-97b8-a189006168a9 34 fields · synced May 30, 2026
- FDA UDI 14e6adac-834a-4e3c-b10c-2e948dffd2ef 34 fields · synced May 30, 2026
- FDA UDI 685d688d-0f19-4cf7-8d51-ddff9ee6aec9 34 fields · synced May 30, 2026
- FDA UDI 822c658e-3f6a-494a-b66e-a673eff21eaf 34 fields · synced May 30, 2026
- FDA UDI c546d854-7bf5-4108-8df5-cfbd01d3169b 34 fields · synced May 30, 2026
- FDA UDI 8ec94597-ad0f-45c2-8083-0b999200d3d1 34 fields · synced May 30, 2026
- FDA UDI 6b34d406-e96d-4c9d-8448-0bc93f00eb9b 34 fields · synced May 30, 2026
- FDA UDI c192d739-3119-4a17-b7eb-8cf3735c2679 34 fields · synced May 30, 2026
- FDA UDI 84bec46b-fe60-4cb1-a1f6-8853169feb06 34 fields · synced May 30, 2026
- FDA UDI 874e92a0-85e1-4a39-b2d8-503443315e04 34 fields · synced May 30, 2026
- FDA UDI a5a5ec9e-5c1e-4a67-a2cb-59243f5b904e 34 fields · synced May 30, 2026
- FDA UDI c9511600-9f0c-49ef-bf8b-5a4bef516607 34 fields · synced May 30, 2026
- FDA UDI a19f72cd-eb0a-4a9d-b43f-5980b921a91c 34 fields · synced May 30, 2026
- FDA UDI 58264903-0166-4c1b-a1b2-9912b05c5e3a 34 fields · synced May 30, 2026
- FDA UDI 1a2230bf-9feb-467a-a103-f67832010f91 34 fields · synced May 30, 2026
- FDA UDI efe233a8-4d85-42ab-abe9-3d450d6fdf6c 34 fields · synced May 30, 2026
- EUDAMED f865d97f-6b2c-4f5c-acf8-c7cbe7cc038d 61 fields · synced Jul 9, 2026
- EUDAMED 6b81c25e-e5eb-480f-871d-97939a297ad9 61 fields · synced Jul 10, 2026
- EUDAMED 5c1c5492-d347-4371-b4e3-1f8703dacb89 61 fields · synced Jul 10, 2026
- EUDAMED e25639aa-d4ab-4a2e-aa3a-3dd796cb96d0 61 fields · synced Jul 10, 2026
- EUDAMED 33a519fb-ad91-407c-a9c6-b910ac356016 61 fields · synced Jul 10, 2026
- EUDAMED a6c61108-fcc5-4ec3-a026-4755aae87f5f 61 fields · synced Jul 10, 2026
- EUDAMED 9794b973-53cd-421a-8b31-847b54c6654b 61 fields · synced Jul 10, 2026
- EUDAMED e6495ecb-4a0b-4fd5-88a2-19fa9aeedb03 61 fields · synced Jul 11, 2026
- EUDAMED 4c0e6626-b904-47ff-9f2d-13e9f928a5e4 61 fields · synced Jul 11, 2026
- EUDAMED 245eabe6-e3b5-4ecf-aa1b-d769e1902232 61 fields · synced Jul 11, 2026
- EUDAMED 97c88777-a504-4bb2-bddf-6f4dffb58be6 61 fields · synced Jul 11, 2026
- EUDAMED 433852a4-887e-48f5-a454-f276c6209fbd 61 fields · synced Jul 13, 2026
- EUDAMED 5c65fff3-4fa0-449b-b6ae-107bddf45a61 61 fields · synced Jul 15, 2026
- EUDAMED ed5c9cfd-f3da-4e8d-b89e-16a1267c1225 61 fields · synced Jul 16, 2026
- EUDAMED 65c3083a-3f32-46ca-90c0-e10d74488a8f 61 fields · synced Jul 18, 2026
- EUDAMED 0da44fd1-82c1-4012-a7c3-5ea1e721fd79 61 fields · synced Jul 19, 2026
- EUDAMED 982b9179-d29a-41b1-8105-b2bf154bfe11 61 fields · synced Jul 19, 2026
- EUDAMED 3180ee1b-37cb-44d4-8d24-37dda98ea703 61 fields · synced Jul 21, 2026
- EUDAMED 83680c23-c74d-4d10-a711-311110e00e45 61 fields · synced Jul 26, 2026
- EUDAMED 0503e1ed-c65f-4f6a-8284-87af4d107a55 61 fields · synced Jul 26, 2026
- EUDAMED 206176ed-7857-40ee-a486-fe7c713f6715 61 fields · synced Jul 28, 2026
- EUDAMED 4b179249-7387-4497-b654-2804b15ccdc6 61 fields · synced Jul 30, 2026
- EUDAMED d84905b2-e8d4-4dbe-909a-c2aab9b0d8cc 61 fields · synced Aug 3, 2026
- EUDAMED caaa8209-3000-4ea9-b45b-f45e28aaa542 61 fields · synced Sep 17, 2026