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Navina Inserts

FDA UDI

Class II (US FDA UDI)

by Renew Medical Inc

Identity

Trade Name
Navina Inserts FDA UDI
Generic Name
Anal plug, single-use FDA UDI
Device Name
Starter Pack of 5 individually packaged Navina Inserts consisting of 3 regular size and 2 large size single shot Inserts FDA UDI
Model / Reference
69301 FDA UDI
Description
Starter Pack of 5 individually packaged Navina Inserts consisting of 3 regular size and 2 large size single shot Inserts FDA UDI

Identifiers

Catalog Number
69301 FDA UDI
Primary DI / UDI-DI
00861680000458 FDA UDI
510(k) Number
K122003 FDA UDI
FDA Product Code
PBP FDA UDI
GMDN Term
Anal plug, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: Anal plug, single-use

Navina Inserts by Renew Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anal plug, single-use.

Cleared under the same submission

K122003 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Renew Medical Inc

Sources (1)

  • FDA UDI 649ae87f-ef05-4141-bb16-a170338c33b0 36 fields · synced Jun 8, 2026