Identity
- Trade Name
- Adroit Surgical FDA UDI
- Generic Name
- Oesophageal bougie, single-use FDA UDI
- Device Name
- The Tactical Voir bougie (coiled tube for package convenience) is for use with an endoctracheal tube 6.0 mm ID and larger for adult patients to guide the direction of the endotracheal tube (ETT) between the vocal cords. The Tactical Voir Bougije has clearly marked colored bands (patent pending) that allow the user to quickly insert the Bougie the correct distance into the trachea. The product has been designed for use by EMS and healthcare practitioners trained and experienced in airway management techniques. FDA UDI
- Model / Reference
- 90546 FDA UDI
- Description
- The Tactical Voir bougie (coiled tube for package convenience) is for use with an endoctracheal tube 6.0 mm ID and larger for adult patients to guide the direction of the endotracheal tube (ETT) between the vocal cords. The Tactical Voir Bougije has clearly marked colored bands (patent pending) that allow the user to quickly insert the Bougie the correct distance into the trachea. The product has been designed for use by EMS and healthcare practitioners trained and experienced in airway management techniques. FDA UDI
Identifiers
- Catalog Number
- VB-3001 FDA UDI
- Primary DI / UDI-DI
- 00859290006229 FDA UDI
- FDA Product Code
- KCD FDA UDI
- GMDN Term
- Oesophageal bougie, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Oesophageal bougie, single-use
Adroit Surgical by Truer Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oesophageal bougie, single-use.
- Bougie Dilator — Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Class II
- TELEFLEX — TELEFLEX INCORPORATED · Class II
- Adroit surgical — TRUER MEDICAL, 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
- Truer Medical, Inc.
Sources (1)
- FDA UDI a22b1bf5-f2cc-4c68-83ed-00bc0bee9102 36 fields · synced Jun 8, 2026