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Renew Inserts

FDA UDI

Class II (US FDA UDI)

by Renew Medical Inc

Identity

Trade Name
Renew Inserts FDA UDI
Generic Name
Anal plug, single-use FDA UDI
Device Name
30 pack carton of individually packaged Renew large size Inserts FDA UDI
Model / Reference
707 FDA UDI
Description
30 pack carton of individually packaged Renew large size Inserts FDA UDI

Identifiers

Catalog Number
707 FDA UDI
Primary DI / UDI-DI
00867476000046 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

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

Category: Anal plug, single-use

Renew 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 5f77b7b9-51be-4f0a-a6f2-5c207613a822 36 fields · synced May 31, 2026