Identity
- Trade Name
- Dilator FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- Dilator, 4.1 x 185mm FDA UDI
- Model / Reference
- 259-410-185 FDA UDI
- Description
- Dilator, 4.1 x 185mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049197524544 FDA UDI
- FDA Product Code
- HNW FDA UDI
- GMDN Term
- Endoscopic-access dilator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic-access dilator, reusable
Dilator by RZ-Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Arthrex® — Arthrex, Inc. · Class I
- TESSYS® — JOIMAX, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- RZ-Medizintechnik GmbH
Sources (1)
- FDA UDI 4b98a474-f18e-4c01-bd94-84ccb7366163 33 fields · synced May 29, 2026