Identity
- Trade Name
- Total Control Introducer™ (TCI) FDA UDI
- Generic Name
- Endotracheal tube introducer, single-use FDA UDI
- Device Name
- Articulating Introducer with detachable handle, intuitive depth system, 70 CM, 15 Fr, latex free, single use, sterile, fits 6.0 and larger ID tubes FDA UDI
- Model / Reference
- 000163 FDA UDI
- Description
- Articulating Introducer with detachable handle, intuitive depth system, 70 CM, 15 Fr, latex free, single use, sterile, fits 6.0 and larger ID tubes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860581002639 FDA UDI
- FDA Product Code
- BSR FDA UDI
- GMDN Term
- Endotracheal tube introducer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5790 FDA UDI
- Commercial Distribution
- Not 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
Total Control Introducer™ (TCI) by Through The Cords, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Through The Cords, Llc
Sources (1)
- FDA UDI 1a6c5193-01d8-4016-b170-5cee86553b4b 35 fields · synced Jun 6, 2026