VICRYL Plus
Ref VCP381HModel Vicryl Plus Antibacterial
Active
CE MDR
Valid until
7 Mar 2028
FDA recalls
1 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | NumberMDR 719661 | Date25 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10705031207554 | Date30 Apr 2026 | StatusListed |
Certificates
- MDR 719661 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 25 Aug 2026
- Expires
- 7 Mar 2028
- Reason
- Other
Recalls
-
- Ongoing Z-2145-2024
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Specification
- Trade Name
- VICRYL Plus EUDAMEDVicryl GUDID
- Generic Name
- Polyester suture, bioabsorbable, multifilament, antimicrobial
- Device Name
- Vicryl Plus Antibacterial Polyglactin 910 Braided Absorbable Suture
- Model / Ref / Catalog
- Vicryl Plus Antibacterial, VCP381H
- Primary DI / UDI-DI
- 10705031207554
- Basic UDI-DI
- 0705031a007935M
- 510(k) Number
- FDA Product Code
- GAM
- EMDN Code
- H010101040201 Polyglycolic acid with lactic acid with antibacterial multifilament with needle
- GMDN Term
- Polyester suture, bioabsorbable, multifilament, antimicrobial
- Device Class
- Class III EUDAMEDClass II GUDID
- Regulation Number
- 878.4493
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class III | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000013111
- Authorised representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Other devices from Ethicon Inc.
Properties
Other properties (16)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No