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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
RIGID ENDOSCOPE 70 DEG. 6MM FDA UDI
Model / Reference
9108 FDA UDI
Description
RIGID ENDOSCOPE 70 DEG. 6MM FDA UDI

Identifiers

Primary DI / UDI-DI
04961333240548 FDA UDI
510(k) Number
K921285 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

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 — 70.0 degree FDA UDI
Outer Diameter — 6.0 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.

Cleared under the same submission

K921285 also covers:

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 e3027455-47ab-4b8a-81f5-f483c101f5c5 35 fields · synced Jun 7, 2026