Identity
- Trade Name
- Susol EUDAMEDSusol® Henckel Tilley Punch Forceps 4.5mm FDA UDI
- Generic Name
- Open-surgery biopsy forceps, single-use FDA UDI
- Device Name
- Susol® Scissors Micro Laryngeal 25cm - Left EUDAMED
- Model / Reference
- SS07-0311L EUDAMEDSS42-3215 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060418833343 EUDAMED05060418834661 FDA UDI
- Basic UDI-DI
- 506041883REGEN38812GY EUDAMED
- Unit of Use DI
- 05060418834661 EUDAMED
- FDA Product Code
- KAE FDA UDI
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Open-surgery biopsy forceps, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: General internal orthopaedic fixation system implantation kit
Susol by Bailey Instruments Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506041883REGEN38812GY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bailey Instruments Ltd.
- EUDAMED SRN
- GB-MF-000013119
- Authorised Representative
- MD REPS Ltd XI-AR-000040375
Sources (2)
- EUDAMED 68b097fa-3030-4d85-a9ef-1fc20a90f1ae 61 fields · synced Jul 20, 2026
- FDA UDI 0905c3b2-60cd-44b6-b93a-abf8bd7feeb6 32 fields · synced May 29, 2026