Identity
- Trade Name
- COOK FDA UDI
- Generic Name
- Endotracheal tube introducer, single-use FDA UDI
- Model / Reference
- G53517 FDA UDI
Identifiers
- Catalog Number
- C-CAE-14.0-70-FIC-SPOPS FDA UDI
- Primary DI / UDI-DI
- 00827002535176 FDA UDI
- 510(k) Number
- K161813 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Endotracheal tube introducer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5730 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
No
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 introducer, single-use
Cook by William Cook Europe ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endotracheal tube introducer, single-use.
- Bougie / Introducer OD 5.0mm (15Ch) 700mm — FLEXICARE MEDICAL LIMITED · Class I
- Frova — COOK INCORPORATED · Class I
- Runnels Steerable Introducer™ #2 Oral/Nasal — THROUGH THE CORDS, LLC · Class I
- Frova — COOK INCORPORATED · Class II
- Truer Bougie — TRUER MEDICAL, INC. · Class I
- Runnels Steerable Introducer™ #4 Oral — THROUGH THE CORDS, LLC · Class I
- Intuitive Depth Bougie™ (IDB), Coude Tip — THROUGH THE CORDS, LLC · Class I
- USB™ UNIVERSAL STYLET BOUGIE 15FR OD 5.0 MM — Intersurgical Incorporated · Class I
Cleared under the same submission
K161813 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- William Cook Europe ApS
Sources (1)
- FDA UDI 0bedb81d-53c7-4200-ac1e-0892c56c373f 36 fields · synced May 31, 2026