← Back to catalogue
Case & Lid, Broken & Stripped Screw V3 System (S9SCREW - Shukla SCREW/ Universa…
EUDAMEDClass I (EU MDR)
Ref SCS054
Identity
- Trade Name
- Case & Lid, Broken & Stripped Screw V3 System (S9SCREW - Shukla SCREW/ Universal Broken & Stripped Screw Extraction Solution) EUDAMED
- Device Name
- Case & Lid, Broken & Stripped Screw V3 System (S9SCREW - Shukla SCREW/ Universal Broken & Stripped Screw Extraction Solution) EUDAMED
- Model / Reference
- SCS054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SCS0540 EUDAMED
- Basic UDI-DI
- ++B756S9SCREWCASEHR EUDAMED
- Direct Marketing DI
- +B756SCS0540 EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Instrument tray, reusable
Case & Lid, Broken & Stripped Screw V3 System (S9SCREW - Shukla SCREW/ Universa… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
Similar devices
Also classified as Instrument tray, reusable.
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
Manufacturer's product page: ScrewFlex
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B756S9SCREWCASEHR | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S. S. White Technologies Inc/DBA Shukla Medical
- EUDAMED SRN
- US-MF-000007058
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 51d8af3e-ccde-44a9-9955-67ad8d5cf725 61 fields · synced Oct 7, 2026