Identity
- Trade Name
- BioSentry™ Tract Sealant System FDA UDI
- Generic Name
- Lung biopsy procedure kit FDA UDI
- Device Name
- BioSentry™ Tract Sealant System FDA UDI
- Model / Reference
- 768022019S FDA UDI
- Description
- BioSentry™ Tract Sealant System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848782023141 FDA UDI
- 510(k) Number
- DEN090007 FDA UDI
- FDA Product Code
- OMT FDA UDI
- GMDN Term
- Lung biopsy procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4755 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
No
FDA UDI
Category: Lung biopsy procedure kit
BioSentry™ Tract Sealant System by Surgical Specialties México, S. de R.L. de C.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lung biopsy procedure kit.
- Archimedies Access Kit with Syringe — BRONCUS MEDICAL INC. · Class II
- BioSentry® — Merit Medical Systems, Inc. · Class II
- Archimedes Access Kit — BRONCUS MEDICAL INC. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgical Specialties México, S. de R.L. de C.V.
Sources (1)
- FDA UDI c6b37d47-f7ce-4110-8ee4-c8f039d17a46 35 fields · synced May 30, 2026