Identity
- Trade Name
- Bougie Stylet FDA UDI
- Generic Name
- Endotracheal tube introducer, single-use FDA UDI
- Device Name
- The Bougie Stylet is intended to be used in conjunction with a video laryngoscope or standard adult laryngoscope device in the guidance and placement of a 6.5 mm or greater endotracheal tube through the periglottic opening. FDA UDI
- Model / Reference
- B62400 FDA UDI
- Description
- The Bougie Stylet is intended to be used in conjunction with a video laryngoscope or standard adult laryngoscope device in the guidance and placement of a 6.5 mm or greater endotracheal tube through the periglottic opening. FDA UDI
Identifiers
- Catalog Number
- B62400 FDA UDI
- Primary DI / UDI-DI
- 00850027063041 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
- 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 introducer, single-use
Bougie Stylet by Wm&Dg — Class I — 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
- COOK — William Cook Europe ApS · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wm&Dg
Sources (1)
- FDA UDI e9768a4c-f9c7-40b9-a1a4-7e45c2e04f7c 34 fields · synced Jun 8, 2026