Identity
- Trade Name
- Sharpsite® FDA UDI
- Generic Name
- Rigid optical nasopharyngoscope FDA UDI
- Device Name
- ENDOSCOPE 1880154 SHARPSITE 4MM/70DEG FDA UDI
- Model / Reference
- 1880154 FDA UDI
- Description
- ENDOSCOPE 1880154 SHARPSITE 4MM/70DEG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169937383 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
- Length — 4.0 Millimeter FDA UDIAngle — 70.0 degree FDA UDI
Category: Rigid optical nasopharyngoscope
Sharpsite® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical nasopharyngoscope.
- RIGID SCOPES — PENTAX of America, Inc. · Class I
- RIGID SCOPES — PENTAX of America, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- ACCLARENT CYCLOPS — ACCLARENT, INC. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- SINUSCOPE — PENTAX of America, Inc. · Class II
- SINUSCOPE — PENTAX of America, Inc. · Class II
- SINUSCOPE — PENTAX of America, Inc. · 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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 5911cee6-8a88-483f-a1f2-a8966bd083fa 35 fields · synced May 30, 2026