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Pentax Endo Smartcap

FDA UDI

Class II (US FDA UDI)

by Medivators Inc.

Identity

Trade Name
PENTAX ENDO SMARTCAP FDA UDI
Generic Name
Endoscopic insufflation tubing set, single-use FDA UDI
Device Name
PENTAX ENDO SMARTCAP FDA UDI
Model / Reference
100551P FDA UDI
Description
PENTAX ENDO SMARTCAP FDA UDI

Identifiers

Primary DI / UDI-DI
00677964060311 FDA UDI
510(k) Number
K093665 FDA UDI
FDA Product Code
FAJ FDA UDI
GMDN Term
Endoscopic insufflation tubing set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Pentax Endo Smartcap by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K093665 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medivators Inc.

Sources (1)

  • FDA UDI 6014cdde-12af-4411-8d94-715e9af12bf4 36 fields · synced Jun 8, 2026