Identity
- Trade Name
- TELEFLEX FDA UDI
- Generic Name
- Oesophageal bougie, single-use FDA UDI
- Device Name
- Standard Precision Bougie Device FDA UDI
- Model / Reference
- IPN928806 FDA UDI
- Description
- Standard Precision Bougie Device FDA UDI
Identifiers
- Catalog Number
- STB38 FDA UDI
- Primary DI / UDI-DI
- 14026704921765 FDA UDI
- 510(k) Number
- K222085 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Oesophageal bougie, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
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: Oesophageal bougie, single-use
Teleflex by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oesophageal bougie, single-use.
- Adroit surgical — TRUER MEDICAL, INC. · Class I
- Adroit Surgical — TRUER MEDICAL, INC. · Class I
- Bougie Dilator — Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Class II
Cleared under the same submission
K222085 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 |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI e7ef728a-c222-46e8-abfb-9ce19a032f90 36 fields · synced May 30, 2026