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Sharpsite®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
SHARPSITE® FDA UDI
Generic Name
Rigid optical nasopharyngoscope FDA UDI
Device Name
ENDOSCOPE 1880155 SHARPSITE 4MM/45DEG FDA UDI
Model / Reference
1880155 FDA UDI
Description
ENDOSCOPE 1880155 SHARPSITE 4MM/45DEG FDA UDI

Identifiers

Primary DI / UDI-DI
00681490046985 FDA UDI
510(k) Number
K965233 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 — 45.0 degree FDA UDI
Outer Diameter — 4.0 Millimeter 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.

Cleared under the same submission

K965233 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI 325a256b-1d86-4420-a200-535c152b4305 36 fields · synced May 30, 2026