Identity
- Trade Name
- eXcelon FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- Transbronchial Aspiration Needle FDA UDI
- Model / Reference
- M00564120 FDA UDI
- Description
- Transbronchial Aspiration Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729748243 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Body aspiration 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: Body aspiration needle, single-use
eXcelon by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Body aspiration needle, single-use.
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- COMPLETE-CHIBA MR — STERYLAB SRL · Class II
- Invivo — Philips DS North America LLC · Class II
- BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
- MReye — COOK INCORPORATED · 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 |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 33f46c39-d9d8-4974-b550-e31d86cda942 34 fields · synced May 31, 2026