Identity
- Trade Name
- AincA® FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
- Device Name
- Brush, Cleaning, Tracheal Tube, 10.5" x 1/4" (6.4mm), Small FDA UDI
- Model / Reference
- 00-458-S FDA UDI
- Description
- Brush, Cleaning, Tracheal Tube, 10.5" x 1/4" (6.4mm), Small FDA UDI
Identifiers
- Catalog Number
- 00-458-S FDA UDI
- Primary DI / UDI-DI
- B00500458S0 FDA UDI
- FDA Product Code
- EPE FDA UDI
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5795 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument/endoscope cleaning utensil, reusable
AincA® by Anesthesia Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/endoscope cleaning utensil, reusable.
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Anesthesia Associates, Inc.
Sources (1)
- FDA UDI e53667ea-f3c6-4d72-9488-f0bb619432f3 36 fields · synced Jun 8, 2026