Identity
- Trade Name
- ViziShot FLEX FDA UDI
- Generic Name
- Flexible endoscopic biopsy handpiece/needle FDA UDI
- Device Name
- Single Use Aspiration Needle FDA UDI
- Model / Reference
- NA-U402SX-4019 FDA UDI
- Description
- Single Use Aspiration Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00896506002132 FDA UDI
- FDA Product Code
- KTI FDA UDI
- GMDN Term
- Flexible endoscopic biopsy handpiece/needle 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible endoscopic biopsy handpiece/needle
ViziShot FLEX by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic biopsy handpiece/needle.
- ClearTip — Finemedix Co., Ltd. · Class II
- ClearTip — Finemedix Co., Ltd. · Class II
- ClearTip — Finemedix Co., Ltd. · Class II
- Disposable Endoscope Injection Needle — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- ELMED — ELMED INCORPORATED · Class I
- ClearTip — Finemedix Co., Ltd. · Class II
- Aspirating Biopsy Needle — Auris Health, Inc. · Class II
- Disposable Endoscope Injection Needle — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · 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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 99cdf1cd-16b1-43b5-8e55-11d7bdf3496b 33 fields · synced Jun 1, 2026