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Leetrac
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel LTNBSModel LTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR Ref LeetracModel LTRWTModel LTRSSModel LTNWT
by B&L Biotech
Identity
- Trade Name
- LEETRAC EUDAMEDLeetrac Narrow Blade FDA UDI
- Generic Name
- Periosteal elevator, reusable FDA UDI
- Device Name
- LEETRAC EUDAMED
- Model / Reference
- LTNBS EUDAMEDFDA UDInone EUDAMEDLTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR EUDAMEDLeetrac EUDAMEDLTRWT EUDAMEDLTRSS EUDAMEDLTNWT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019110941 EUDAMEDFDA UDI08800019110910 EUDAMED08800019110927 EUDAMED08800019110996 EUDAMED
- Basic UDI-DI
- B-08800019110941 EUDAMED88000191LEETRACK4 EUDAMEDB-08800019110910 EUDAMEDB-08800019110927 EUDAMEDB-08800019110996 EUDAMED
- FDA Product Code
- EMO FDA UDI
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Periosteal elevator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Poland EUDAMEDDenmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Leetrac by B&L Biotech — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800019110941 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800019110941 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- B&L Biotech
- EUDAMED SRN
- KR-MF-000023296
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (9)
- EUDAMED 2f5093f4-4d6a-43bc-b1ae-84bc1adbb6e9 61 fields · synced Jul 29, 2026
- EUDAMED 6998c518-765b-4305-8d00-be5189a5ba6b 61 fields · synced May 17, 2026
- FDA UDI eccd65bd-8004-4546-8324-60303987c29f 32 fields · synced May 30, 2026
- EUDAMED 6998c518-765b-4305-8d00-be5189a5ba6b-1 61 fields · synced Jun 9, 2026
- EUDAMED ed74713c-153e-4cf1-bc3c-275864dcb67b 61 fields · synced Jun 18, 2026
- EUDAMED e122fff8-4ba2-4676-8dcb-3a71c88159f6 61 fields · synced Jul 11, 2026
- EUDAMED ca4f66e0-dd6e-4f0a-ba30-cacd7cb928a5 61 fields · synced Jul 18, 2026
- EUDAMED 75a701ad-924c-46a1-bdd4-60bff9623f34 61 fields · synced Jul 22, 2026
- EUDAMED 1569a189-c8de-4d9d-a8db-64703e62a16f 61 fields · synced Jul 29, 2026