Identity
- Trade Name
- AincA® FDA UDI
- Generic Name
- Artificial airway stylet, reusable FDA UDI
- Device Name
- Stylet, Lighted, Malleable Fiber Optic, Pediatric (3mm ETT Min), w/Handle (Req 2 AA), ETT Stop, Copper/CPB FDA UDI
- Model / Reference
- 00-470 FDA UDI
- Description
- Stylet, Lighted, Malleable Fiber Optic, Pediatric (3mm ETT Min), w/Handle (Req 2 AA), ETT Stop, Copper/CPB FDA UDI
Identifiers
- Catalog Number
- 00-470 FDA UDI
- Primary DI / UDI-DI
- B005004700 FDA UDI
- FDA Product Code
- BSR FDA UDI
- GMDN Term
- Artificial airway stylet, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5790 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: Artificial airway stylet, reusable
AincA® by Anesthesia Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Artificial airway stylet, reusable.
- UE Intubation Stylet — Zhejiang UE Medical Corp · Class I
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- Insighter — Shenzhen Insighters Medical Technology Co., Ltd. · Class I
- UE Intubation Stylet — Zhejiang UE Medical Corp · Class I
- UE Intubation Stylet — Zhejiang UE Medical Corp · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- AincA® — Anesthesia Associates, 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 e242779e-04a5-4496-941d-425c037c6389 36 fields · synced May 30, 2026