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Rigid Scopes

FDA UDI

Class I (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name
RIGID SCOPES FDA UDI
Generic Name
Rigid optical nasopharyngoscope FDA UDI
Device Name
RIDID ENDOSCOPE,STERRAD NX CO FDA UDI
Model / Reference
9109 FDA UDI
Description
RIDID ENDOSCOPE,STERRAD NX CO FDA UDI

Identifiers

Primary DI / UDI-DI
04961333240555 FDA UDI
FDA Product Code
EQL FDA UDI
GMDN Term
Rigid optical nasopharyngoscope FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4750 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

No

FDA UDI

Dimensions & Sizes

Size
Angle — 70.0 degree FDA UDI
Outer Diameter — 8.5 Millimeter FDA UDI

Category: Rigid optical nasopharyngoscope

Rigid Scopes by PENTAX of America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical nasopharyngoscope.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PENTAX of America, Inc.

Sources (1)

  • FDA UDI 113aa9ea-bedb-4a8e-ab0d-45244947fc0b 34 fields · synced May 30, 2026