Quill PDO
EUDAMEDFDA UDIClass III (EU MDR)
Identity
- Trade Name
- Quill PDO EUDAMED0 Pdo 36 X 36 FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
- Device Name
- Quill PDO EUDAMED0 Pdo 36 X 36 FDA UDI
- Model / Reference
- Quill™ PDO (Polydioxanone) EUDAMEDRX-2069Q EUDAMEDFDA UDI
- Description
- 0 Pdo 36 X 36 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848782019625 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00848782019625 EUDAMED
- FDA Product Code
- NEW FDA UDI
- EMDN Code
- H010101010101 POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
- GMDN Term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4840 FDA UDI
- Market of Registration
- Germany 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: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Quill PDO by Surgical Specialties México, S. de R.L. de C.V. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
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- Maxon — Covidien LP · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00848782019625 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Surgical Specialties Mexico S. DE R.L. DE C.V.
- EUDAMED SRN
- MX-MF-000015841
- Authorised Representative
- FSSB Chirurgische Nadeln GmbH DE-AR-000005767
Sources (2)
- EUDAMED efb07fd4-e75a-4ddd-b62e-0aef6a358b7b 61 fields · synced Jul 24, 2026
- FDA UDI 706a700a-2eec-42c6-994f-4ee399932e53 35 fields · synced May 30, 2026