Identity
- Trade Name
- QuickSteer Introducer FDA UDI
- Generic Name
- Endotracheal tube guide, single-use FDA UDI
- Device Name
- Articulating Introducer with detachable handle, latex free, single use, sterile, fits 6.5 and larger ID tubes FDA UDI
- Model / Reference
- 10000-500 FDA UDI
- Description
- Articulating Introducer with detachable handle, latex free, single use, sterile, fits 6.5 and larger ID tubes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009688407 FDA UDI
- FDA Product Code
- BSR FDA UDI
- GMDN Term
- Endotracheal tube guide, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endotracheal tube guide, single-use
QuickSteer Introducer by Tjb Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endotracheal tube guide, single-use.
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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
- Tjb Medical, Inc.
Sources (1)
- FDA UDI f34f2974-c5b1-46b7-a591-b5e9eb2f7437 33 fields · synced Jun 1, 2026