Identity
- Trade Name
- SafeGuide® FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
- Device Name
- Cleaning Brush - Reusable FDA UDI
- Model / Reference
- 1214-03RS FDA UDI
- Description
- Cleaning Brush - Reusable FDA UDI
Identifiers
- Catalog Number
- 1214-03RS FDA UDI
- Primary DI / UDI-DI
- 00816734021019 FDA UDI
- FDA Product Code
- KNQ FDA UDI
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5365 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 86 Centimeter FDA UDI
Category: Surgical instrument/endoscope cleaning utensil, reusable
SafeGuide® by Diversatek Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/endoscope cleaning utensil, reusable.
- LEOS Cannulated Screw System — Tyber Medical · Class I
- MIDAS REX — Medtronic Powered Surgical Solutions · Class I
- FUJIFILM — FUJIFILM Corporation · Class I
- 80000 Series Reusable General and Rigid Cleaning Brush — Primed Instruments Inc · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- SafeClean ® General Purpose Brush — Aspen Surgical Products, Inc. · Class I
- 80000 Series Reusable General and Rigid Cleaning Brush — Primed Instruments Inc · Class I
- Patterson® — PATTERSON DENTAL SUPPLY, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Diversatek Healthcare
Sources (1)
- FDA UDI 28882050-40ea-45e3-9d81-8144ee43d18a 36 fields · synced May 30, 2026