Identity
- Trade Name
- Beacon FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- EUS Access System Preloaded 18.5 G Access Needle 0.035 Inch Guidewire Compatible FDA UDI
- Model / Reference
- DSA-135-01 FDA UDI
- Description
- EUS Access System Preloaded 18.5 G Access Needle 0.035 Inch Guidewire Compatible FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521663527 FDA UDI
- 510(k) Number
- K180037 FDA UDI
- FDA Product Code
- FCG FDA UDI
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
Dimensions & Sizes
- Size
- Angle — 135 degree FDA UDI
Category: General-purpose endoscopic needle, single-use
Beacon by Covidien LP — 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
Cleared under the same submission
K180037 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
- Covidien LP
Sources (1)
- FDA UDI 4bcc10c5-15d1-48c1-aebb-d545b4bb6e36 37 fields · synced May 30, 2026