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Susol
EUDAMEDFDA UDIClass I (EU MDR)
Ref S-DB4Ref SS04-0110FModel SS04-0100Ref SS34-7056Model SS07-0311LRef SS34-2879Model SS30-2601
Identity
- Trade Name
- Susol EUDAMEDSusol® Diamond Bur Pear 1 FDA UDI
- Generic Name
- Podiatric bur, single-use FDA UDI
- Device Name
- Susol® Podiatry Set EUDAMEDSusol® Scalpel Handle No.3 EUDAMEDSusol® Scissors Micro Laryngeal 25cm - Left EUDAMEDSusol® Forceps Magill Intubation Adult 24cm EUDAMED
- Model / Reference
- S-DB4 EUDAMEDFDA UDISS04-0100 EUDAMEDSS04-0110F EUDAMEDSS07-0311L EUDAMEDSS34-7056 EUDAMEDSS30-2601 EUDAMEDSS34-2879 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060418833725 EUDAMEDFDA UDI05060418837525 EUDAMED05060418833251 EUDAMED05060418833145 EUDAMED
- Basic UDI-DI
- 506041883SSGEN56303TD EUDAMED506041883SSPOD6327023 EUDAMED506041883REGEN38812GY EUDAMED506041883REGEN11791FA EUDAMED
- Unit of Use DI
- 05060418837518 EUDAMED05060418834579 EUDAMED05060418834463 EUDAMED
- FDA Product Code
- GFF FDA UDI
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMEDV901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Podiatric bur, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Northern Ireland 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cranial bur, single-use
Susol by Bailey Instruments Ltd — 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 | 506041883SSGEN56303TD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bailey Instruments Ltd.
- EUDAMED SRN
- GB-MF-000013119
- Authorised Representative
- MD REPS Ltd XI-AR-000040375
Sources (5)
- EUDAMED 22de2abd-da19-43ef-a225-075467f2aa32 61 fields · synced Jul 24, 2026
- EUDAMED c285542d-6fe8-4376-a0c4-01f7940955c8 61 fields · synced May 16, 2026
- EUDAMED e52b7234-eb8b-4744-b4ab-5b5acd7e5341 61 fields · synced May 17, 2026
- EUDAMED bc1259bd-f245-4b28-9838-71e05ba559cd 61 fields · synced May 17, 2026
- FDA UDI 77b62e72-cd39-48b0-8b54-f88b63c13172 32 fields · synced May 30, 2026