Identity
- Trade Name
- PrimeSight FDA UDI
- Generic Name
- Rigid optical sinoscope FDA UDI
- Device Name
- Sinuscope 2.7 x 187 mm, 0° FDA UDI
- Model / Reference
- 02-4318 FDA UDI
- Description
- Sinuscope 2.7 x 187 mm, 0° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250480106358 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Rigid optical sinoscope 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Rigid optical sinoscope
PrimeSight by SCHÖLLY FIBEROPTIC GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical sinoscope.
- JEDMED — JEDMED Instrument Company · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- SINUSCOPE — Ecleris · Class II
- JEDMED — JEDMED Instrument Company · Class II
- JEDMED — JEDMED Instrument Company · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Integra® Jarit® — Integra LifeSciences Production Corporation · 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
- SCHÖLLY FIBEROPTIC GmbH
Sources (1)
- FDA UDI 52a2b7c8-58a8-4c70-aab7-e4aec11e62b6 36 fields · synced Jun 1, 2026