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Prolene

FDA UDI

Class II (US FDA UDI)

by Ethicon Inc.

Identity

Trade Name
PROLENE FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Device Name
Polypropylene Nonabsorbable Synthetic Surgical Mesh FDA UDI
Model / Reference
PHSL FDA UDI
Description
Polypropylene Nonabsorbable Synthetic Surgical Mesh FDA UDI

Identifiers

Catalog Number
PHSL, PHSL1, PHSL6 FDA UDI
Primary DI / UDI-DI
10705031048966 FDA UDI
510(k) Number
K180829 FDA UDI
K984220 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
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

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Prolene by Ethicon Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.

Cleared under the same submission

K180829 also covers:

K984220 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Inc.

Sources (1)

  • FDA UDI 2d56fbdf-360c-4355-b9d6-dbf13a6a24f3 36 fields · synced May 30, 2026