Identity
- Trade Name
- Crown Reamer red, coarse, reusable EUDAMEDcrown cutter FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- CESSYS® Cervical Reamer EUDAMEDCrown Reamer red, coarse, reusable FDA UDI
- Model / Reference
- CRC216575R EUDAMEDFDA UDI
- Description
- Crown Reamer red, coarse, reusable FDA UDI
Identifiers
- Catalog Number
- CRC216575R FDA UDI
- Primary DI / UDI-DI
- 04250337118084 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371REAMREAFD EUDAMED
- Direct Marketing DI
- 04250337118084 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L1113 NEUROSURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Endoscopic-access dilator, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 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: Endoscopic-access dilator, reusable
crown cutter by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic-access dilator, reusable.
- Target Endoscopic Instrument — SOLENDOS Inc. · Class I
- Simpact Tri-Fin — Life Spine, Inc. · Class II
- Percutaneous Nephrostomy Dilator — Well Lead Medical Co., Ltd · Class I
- Arthrex® — Arthrex, Inc. · Class I
- AVATAR Minimally Invasive Spinal System — Life Spine, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- T-FIX™3Dsi Joint Fusion System — CUTTING EDGE SPINE · Class II
- MaxMoreSpine — Hoogland Spine Products, GmbH · 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 d42e77fe-cf77-4e23-847d-e198257cd1c6 36 fields · synced Jul 24, 2026
- EUDAMED 65d84215-e71d-43d5-92d8-0223228f92b9 61 fields · synced Jul 24, 2026