Prolene
FDA UDIEUDAMEDClass II (US FDA UDI)
by Ethicon Inc.
Identity
- Trade Name
- PROLENE EUDAMEDFDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
- Device Name
- PROLENE Suture EUDAMEDBlue Monofilament (Polypropylene), Nonabsorbable Surgical Suture FDA UDI
- Model / Reference
- W2777 EUDAMEDFDA UDIPROLENE Suture EUDAMED
- Description
- Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture FDA UDI
Identifiers
- Catalog Number
- W2777 FDA UDI
- Primary DI / UDI-DI
- 10705031126039 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705031a012584Z EUDAMED
- 510(k) Number
- K133356 FDA UDI
- FDA Product Code
- GAW FDA UDI
- EMDN Code
- H010201010401,H010201010402 EUDAMED
- GMDN Term
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5010 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Polyolefin/fluoropolymer suture, monofilament
Prolene by Ethicon Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Polyolefin/fluoropolymer suture, monofilament.
- SUTUMED — Unilene Sac · Class II
- DemeLENE — DemeTECH Corp · Class II
- DemeLENE — DemeTECH Corp · Class II
- ATRAMAT — Internacional Farmacéutica S.A DE C.V · Class II
- DemeLENE — DemeTECH Corp · Class II
- WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- Premilene — B BRAUN SURGICAL SA · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K133356 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Inc.
Sources (2)
- FDA UDI c79c6624-3da4-4266-af4b-9f8e2f7f4084 36 fields · synced Oct 11, 2026
- EUDAMED 1411069c-79db-409c-bc7d-e5f8ba60dad6 61 fields · synced Oct 11, 2026