Identity
- Trade Name
- EchoTip FDA UDI
- Generic Name
- Ultrasound aspiration biopsy procedure kit FDA UDI
- Device Name
- Echotip Ultra, Endobronchial High Definition Ultrasound Needle FDA UDI
- Model / Reference
- G24062 FDA UDI
- Description
- Echotip Ultra, Endobronchial High Definition Ultrasound Needle FDA UDI
Identifiers
- Catalog Number
- ECHO-HD-25-EBUS-O FDA UDI
- Primary DI / UDI-DI
- 00827002240629 FDA UDI
- FDA Product Code
- FCG FDA UDI
- GMDN Term
- Ultrasound aspiration biopsy procedure kit 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
Yes
FDA UDI
Category: Ultrasound aspiration biopsy procedure kit
EchoTip by Cook Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound aspiration biopsy procedure kit.
- Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) — Micro-Tech (Nanjing) Co., Ltd. · Class II
- ClearView — Medi-Globe Corporation · Class II
- SonoTip Pro Control — Medi-Globe Corporation · Class II
- ClearView — Medi-Globe Corporation · Class II
- Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Trident(TM) Endoscopic Ultrasound Biopsy Needle (FNB) — Micro-Tech (Nanjing) Co., Ltd. · Class II
- SonoTip Pro Control — Medi-Globe Corporation · 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
- Cook Ireland, Ltd.
Sources (1)
- FDA UDI 25276633-57d7-475b-b975-279da11037b3 36 fields · synced May 29, 2026