Identity
- Trade Name
- SINUSCOPES FDA UDI
- Generic Name
- Rigid optical nasopharyngoscope FDA UDI
- Device Name
- Sinuscope 2.7mm, 70 Wide Angle FDA UDI
- Model / Reference
- 8852-WA FDA UDI
- Description
- Sinuscope 2.7mm, 70 Wide Angle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333230532 FDA UDI
- 510(k) Number
- K944656 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Rigid optical nasopharyngoscope 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
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 70 degree FDA UDIOuter Diameter — 2.7 Millimeter FDA UDI
Category: Rigid optical nasopharyngoscope
Sinuscopes by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rigid optical nasopharyngoscope.
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Cleared under the same submission
K944656 also covers:
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- SINUSCOPE — PENTAX of America, Inc.
- SINUSCOPE — PENTAX of America, Inc.
- SINUSCOPE — PENTAX of America, Inc.
- SINUSCOPE — PENTAX of America, Inc.
- SINUSCOPE — PENTAX of America, Inc.
- Handle for sinuscope — SOPRO-COMEG GmbH
- Handle for sinuscope — SOPRO-COMEG GmbH
- Handle for sinuscope — SOPRO-COMEG GmbH
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
- PENTAX of America, Inc.
Sources (1)
- FDA UDI ccfe9915-4d5c-4d74-a784-daf744ec19b2 35 fields · synced Jun 6, 2026