Identity
- Trade Name
- Susol EUDAMEDSusol® Diamond Bur Bud 1 FDA UDI
- Generic Name
- Podiatric bur, single-use FDA UDI
- Device Name
- Susol® Podiatry Set EUDAMED
- Model / Reference
- S-DB2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060418833701 EUDAMEDFDA UDI
- Basic UDI-DI
- 506041883SSGEN56303TD EUDAMED
- FDA Product Code
- GFF FDA UDI
- EMDN Code
- V0199 CUTTING DEVICES, 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 (2)
- EUDAMED f267908c-296f-47e6-b304-eda385676ffd 61 fields · synced Jul 9, 2026
- FDA UDI 246c9dc1-01e1-440b-904f-98c5dc7194f8 32 fields · synced May 30, 2026