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Reducing sleeve
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref RTFS243746
by Joimax, Inc.
Identity
- Trade Name
- Reduction Tube for Foraminoscopes WCh 4.7 mm EUDAMEDReducing sleeve FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- Reduction Tube for Laminoscopes WCh 4.7 mm EUDAMEDReduction Tube for Foraminoscopes WCh 4.7 mm FDA UDI
- Model / Reference
- RTFS243746 EUDAMEDFDA UDI
- Description
- Reduction Tube for Foraminoscopes WCh 4.7 mm FDA UDI
Identifiers
- Catalog Number
- RTFS243746 FDA UDI
- Primary DI / UDI-DI
- 04250337115205 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371ENSCRTDK EUDAMED
- Direct Marketing DI
- 04250337115205 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Spinal endoscopic-access system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal endoscopic-access system
Reducing sleeve by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal endoscopic-access system.
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- Trephine — ELLIQUENCE LLC · Class I
- Kerrison — ELLIQUENCE LLC · Class I
- Medfix — Medfix International, LLC · Class I
- Working Tube — ELLIQUENCE LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 45db0e8d-e8f0-4c32-9eb5-fd71c1c7b23a 36 fields · synced Jul 14, 2026
- EUDAMED e5759670-ff6d-4f63-a01e-25149f35b844 61 fields · synced Jul 14, 2026