Identity
- Trade Name
- SonoTip® EBUS Pro Flex FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- SonoTip EBUS Pro with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Pentax Endoscope, 22 Gauge Needle System, Round Nitinol Stylet, Needle ø 0.7 mm, outer ø 1.8 mm, plastic sheath FDA UDI
- Model / Reference
- GUS-42-18-022 FDA UDI
- Description
- SonoTip EBUS Pro with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Pentax Endoscope, 22 Gauge Needle System, Round Nitinol Stylet, Needle ø 0.7 mm, outer ø 1.8 mm, plastic sheath FDA UDI
Identifiers
- Catalog Number
- GUS-42-18-022 FDA UDI
- Primary DI / UDI-DI
- 04052838011457 FDA UDI
- FDA Product Code
- FCG FDA UDI
- GMDN Term
- Body aspiration 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 22 Gauge FDA UDI
Category: Body aspiration needle, single-use
SonoTip® EBUS Pro Flex by Medi-Globe Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medi-Globe Corporation
Sources (1)
- FDA UDI 3aada385-ca49-4c99-b841-2274323a8c36 37 fields · synced Jun 6, 2026