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Plug T5

FDA UDI

Class II (US FDA UDI)

by Herniamesh

Identity

Trade Name
Plug T5 FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Device Name
T5 cm 6,5x10 is a semirigid pre-shaped mesh with eccentric hole knitted with Polypropylene monofilament, indicated for use in inguinal hernia repairs when there is a significant destruction or weakness of the posterior wall. FDA UDI
Model / Reference
PT50-S FDA UDI
Description
T5 cm 6,5x10 is a semirigid pre-shaped mesh with eccentric hole knitted with Polypropylene monofilament, indicated for use in inguinal hernia repairs when there is a significant destruction or weakness of the posterior wall. FDA UDI

Identifiers

Primary DI / UDI-DI
58032919891193 FDA UDI
510(k) Number
K973955 FDA UDI
FDA Product Code
FTL FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 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

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

Yes

FDA UDI

Plug T5 by Herniamesh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K973955 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Herniamesh

Sources (1)

  • FDA UDI f1d02936-0fe4-40d9-9001-f287f24ac7dd 35 fields · synced Jun 6, 2026