Identity
- Trade Name
- BioStar Transbronchial Aspiration Needle FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- The BioStar® Transbronchial Aspiration Needle is a sterile single-use disposable catheter with a coring needle in a protective sheath that directly connects to standard flexible optical bronchoscopes with a working channel of not less than 1.7 mm. FDA UDI
- Model / Reference
- iS237 FDA UDI
- Description
- The BioStar® Transbronchial Aspiration Needle is a sterile single-use disposable catheter with a coring needle in a protective sheath that directly connects to standard flexible optical bronchoscopes with a working channel of not less than 1.7 mm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08565710078012 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 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: General-purpose endoscopic needle, single-use
BioStar Transbronchial Aspiration Needle by Broncus Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose endoscopic needle, single-use.
- Single Use Aspiration Needle NA-U201H — Olympus Medical Systems Corporation · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- Porges Coloplast — Coloplast A/S · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- Injectra, ScleroTip — Medi-Globe Corporation · Class II
- Single Use Injector NM600/610 — Olympus Medical Systems Corporation · Class II
- Single Use Aspiration Needle NA-U401SX — Olympus Medical Systems Corporation · Class II
- Henry Schein — HENRY SCHEIN, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Broncus Medical Inc.
Sources (1)
- FDA UDI 896f90e4-0a35-4e1b-a1a9-c72da47d3256 33 fields · synced Jun 8, 2026