Quill PDO
by Surgical Specialties Mexico S. DE R.L. DE C.V. 119 variants
Ref VLP-2020Model Quill™ PDO (Polydioxanone)
Quill PDO (VLP-2020) is a device classified as Class III in the EU and Class II in the US made by Surgical Specialties México, S. de R.L. de C.V., registered in EUDAMED on 2 Jul 2024 (Basic UDI-DI B-00848782020881) and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 00848782020881), active as of 22 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00848782020881 00848782020881 | Date2 Jul 2024 | StatusActive |
| United States | GUDID listing GUDID | Number00848782020881 | Date22 Oct 2015 | StatusListed |
Official records
- EUDAMED public site B-00848782020881
- AccessGUDID record 00848782020881
Across registries
- EUDAMED Basic UDI-DI B-00848782020881 registered 2 Jul 2024 Active
- FDA GUDID UDI-DI 00848782020881 listed 22 Oct 2015 Listed
Timeline
- Listed FDA GUDID 00848782020881
- Registered EUDAMED B-00848782020881
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Quill PDO EUDAMED2-0 Uni Pdo 20cm GUDID
- Generic name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial
- Model / reference
- Quill™ PDO (Polydioxanone), VLP-2020
- Primary DI / UDI-DI
- 00848782020881
- Basic UDI-DI
- B-00848782020881
- FDA product code
- NEW
- EMDN code
- H010101010101 Polydioxanone monofilament with needle for open surgery
- GMDN term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial
- Device class
- Class III EUDAMEDClass II GUDID
- Regulation number
- 878.4840
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class III | Class II |
Manufacturer details
- EUDAMED SRN
- MX-MF-000015841
- Authorised representative
- FSSB Chirurgische Nadeln GmbH DE-AR-000005767
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