Identity
- Trade Name
- VERTEBRIS FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- DILATOR ID 1.1MM OD 9.4MM for single-stage dilatation, TL 235mm, reusable FDA UDI
- Model / Reference
- 892209510 FDA UDI
- Description
- DILATOR ID 1.1MM OD 9.4MM for single-stage dilatation, TL 235mm, reusable FDA UDI
Identifiers
- Catalog Number
- 892209510 FDA UDI
- Primary DI / UDI-DI
- 04055207035344 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Endoscopic-access dilator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 1.1 Millimeter FDA UDIOuter Diameter — 9.4 Millimeter FDA UDI
Category: Endoscopic-access dilator, reusable
Vertebris by Richard Wolf GmbH — Class I — FDA UDI — listed in FDA GUDID — 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
- iLESSYS® — JOIMAX, INC. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Richard Wolf GmbH
Sources (1)
- FDA UDI da32fa1c-2b60-4d5e-9639-6f69efe01777 36 fields · synced May 30, 2026