Identity
- Trade Name
- PrimeSight FDA UDI
- Generic Name
- Rigid optical laryngopharyngoscope FDA UDI
- Device Name
- Laryngoscope 10 x 186 mm, 90° FDA UDI
- Model / Reference
- 02-4316 FDA UDI
- Description
- Laryngoscope 10 x 186 mm, 90° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250480107355 FDA UDI
- FDA Product Code
- CCW FDA UDI
- GMDN Term
- Rigid optical laryngopharyngoscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5540 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
Yes
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 laryngopharyngoscope
PrimeSight by SCHÖLLY FIBEROPTIC GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- GlideScope® — Verathon Medical (Canada) ULC · Class I
- GlideScope® — Verathon Medical (Canada) ULC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- SCHÖLLY FIBEROPTIC GmbH
Sources (1)
- FDA UDI 8bf2c5f3-dfd0-49c9-a9bb-82f29d6ae48b 36 fields · synced May 30, 2026