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MENTOR Tissue Expander

FDA UDI

Class U (US FDA UDI)

by Mentor Texas LP

Identity

Trade Name
MENTOR Tissue Expander FDA UDI
Generic Name
Skin-port tissue expander FDA UDI
Device Name
Smooth Round, 1000cc FDA UDI
Model / Reference
3504306M FDA UDI
Description
Smooth Round, 1000cc FDA UDI

Identifiers

Catalog Number
350-4306M FDA UDI
Primary DI / UDI-DI
00081317002420 FDA UDI
510(k) Number
K842883 FDA UDI
FDA Product Code
LCJ FDA UDI
GMDN Term
Skin-port tissue expander FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

MENTOR Tissue Expander by Mentor Texas LP — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K842883 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mentor Texas LP

Sources (1)

  • FDA UDI 46c43c96-4a9f-4a20-8644-5b759ebadc00 37 fields · synced May 30, 2026