Identity
- Trade Name
- Peregrine drivable ENT scope FDA UDI
- Generic Name
- Flexible video otorhinolaryngoscope, single-use FDA UDI
- Device Name
- The Peregrine Drivable ENT Scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscopy procedures. FDA UDI
- Model / Reference
- SWY-0100 FDA UDI
- Description
- The Peregrine Drivable ENT Scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscopy procedures. FDA UDI
Identifiers
- Catalog Number
- SWY-0100 FDA UDI
- Primary DI / UDI-DI
- 07290016539073 FDA UDI
- 510(k) Number
- K202727 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Flexible video otorhinolaryngoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 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: Flexible video otorhinolaryngoscope, single-use
Peregrine drivable ENT scope by 3nt Medical , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video otorhinolaryngoscope, single-use.
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- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
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- aScope™ 4 RhinoLaryngo Slim — Ambu A/S · Class II
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- aScope™ 4 RhinoLaryngo Slim — Ambu A/S · Class II
- Single-Use Rhinolaryngoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument 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
- 3nt Medical , Ltd.
Sources (1)
- FDA UDI 75a9a5f9-74a4-466a-a614-e658c7daf3cd 35 fields · synced May 31, 2026