Identity
- Trade Name
- Neoscope FDA UDI
- Generic Name
- Flexible video bronchoscope, single-use FDA UDI
- Device Name
- NEOFLEX - FLEXIBLE VIDEO BRONCHOSCOPE FDA UDI
- Model / Reference
- NBF 65 FDA UDI
- Description
- NEOFLEX - FLEXIBLE VIDEO BRONCHOSCOPE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851545007579 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Flexible video bronchoscope, single-use 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
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
- Outer Diameter — 6.5 Millimeter FDA UDI
Category: Flexible video bronchoscope, single-use
Neoscope by Prosurg, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video bronchoscope, single-use.
- aScope™ 5 Broncho HD 5.0/2.2 Sampler Set — Ambu A/S · Class II
- aScope™ 4 Broncho Slim 3.8/1.2 — Ambu A/S · Class II
- Single-Use flexible Video Bronchoscope — HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. · Class II
- aScope™ 4 Broncho Large 5.8/2.8 — Ambu A/S · Class II
- Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- aScope™ 5 Broncho 4.2/2.2 Sampler Set — Ambu A/S · Class II
- Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- GlideScope® — Verathon Medical (Canada) ULC · 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
- Prosurg, Inc
Sources (1)
- FDA UDI 1816c401-29eb-4c94-8f86-618df02a7f8c 35 fields · synced Jun 6, 2026