Quill PPN
by Surgical Specialties Mexico S. DE R.L. DE C.V. Mexico EUDAMEDGUDID
Ref VLO-4205Model Quill Polypropylene Knotless Tissue-Closure Device Sterile Barbed Polypropylene Sutures
Product code GAWEMDN H010201010401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00848782037148 | Date2 Jul 2024 | StatusActive |
| United States | GUDID listing GUDID | Number00848782037148 | Date21 Aug 2021 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Quill PPN EUDAMEDQuill GUDID
- Generic Name
- Polyolefin/fluoropolymer suture, monofilament
- Device Name
- Quill PNN
- Model / Ref / Catalog
- Quill Polypropylene Knotless Tissue-Closure Device Sterile Barbed Polypropylene Sutures, VLO-4205
- Primary DI / UDI-DI
- 00848782037148
- Basic UDI-DI
- B-00848782037148
- 510(k) Number
- FDA Product Code
- GAW
- EMDN Code
- H010201010401 Polypropylene monofilament with needle for open surgery
- GMDN Term
- Polyolefin/fluoropolymer suture, monofilament
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 878.5010
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
| Implantable | No | Yes |
Manufacturer details
- EUDAMED SRN
- MX-MF-000015841
- Authorised representative
- FSSB Chirurgische Nadeln GmbH DE-AR-000005767
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Properties & raw data
Show properties, registry sources and raw records
Other properties (18)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED f57aadfc-6ff9-44d5-8ba8-6fa22611b680
- FDA UDI f589a294-7a00-4fa3-bab4-8e0888c63e9d