Identity
- Trade Name
- NeedleView 30 Degree 100mm Scope Kit FDA UDI
- Generic Name
- Endoscopic video imaging system FDA UDI
- Device Name
- 1.4mm NeedleView 30 Degree 100mm Scope Kit FDA UDI
- Model / Reference
- BVTKIT75-3R1A0 FDA UDI
- Description
- 1.4mm NeedleView 30 Degree 100mm Scope Kit FDA UDI
Identifiers
- Catalog Number
- BVTKIT75-3R1A0 FDA UDI
- Primary DI / UDI-DI
- 00851582006177 FDA UDI
- 510(k) Number
- K082293 FDA UDI
- FDA Product Code
- GCJ FDA UDIHRX FDA UDI
- GMDN Term
- Endoscopic video imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI888.1100 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
- Length — 100 Millimeter FDA UDIAngle — 30 degree FDA UDIOuter Diameter — 1.4 Millimeter FDA UDI
Category: Endoscopic video imaging system
NeedleView 30 Degree 100mm Scope Kit by Biovision Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K082293 also covers:
- ONPOINT — BIOMET MICROFIXATION, INC
- 1.2mm InnerVue II Scope Kit — BIOVISION TECHNOLOGIES, LLC
- InnerVue II 100mm Scope Kit — BIOVISION TECHNOLOGIES, LLC
- NeedleView 0 Degree 100mm Scope Kit — BIOVISION TECHNOLOGIES, LLC
- NeedleView 0 Degree 65mm Scope Kit — BIOVISION TECHNOLOGIES, LLC
- NeedleView 10 Degree 100mm Scope Kit — BIOVISION TECHNOLOGIES, LLC
- NeedleView 10 Degree 65mm Scope Kit — BIOVISION TECHNOLOGIES, LLC
- NeedleView 30 Degree 65mm Scope Kit — BIOVISION TECHNOLOGIES, LLC
- OnPoint Disposable Scope Kit — BIOVISION TECHNOLOGIES, LLC
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
- Biovision Technologies, Llc
Sources (1)
- FDA UDI 7c039c02-f94c-40bc-96ac-0cd5a8776b0e 37 fields · synced May 30, 2026