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Arcwave by pjur

FDA UDI

Class II (US FDA UDI)

by Pjur Group Luxembourg SA

Identity

Trade Name
Arcwave by pjur FDA UDI
Generic Name
Sexual lubricant FDA UDI
Device Name
Water-based Personal Lubricant FDA UDI
Model / Reference
Arcwave by pjur - 100ml - USA FDA UDI
Description
Water-based Personal Lubricant FDA UDI

Identifiers

Primary DI / UDI-DI
00827160114732 FDA UDI
510(k) Number
K010199 FDA UDI
FDA Product Code
NUC FDA UDI
GMDN Term
Sexual lubricant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.5300 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Arcwave by pjur by Pjur Group Luxembourg SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K010199 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pjur Group Luxembourg SA

Sources (1)

  • FDA UDI 352ad446-7591-43c6-8eb8-03ea3c8cba91 35 fields · synced May 30, 2026