Identity
- Trade Name
- ASSUFIL MONOFILAMENTO FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
- Model / Reference
- 06F.L.12DN/7/S/C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 58033439196751 FDA UDI
- 510(k) Number
- K150553 FDA UDI
- FDA Product Code
- NEW FDA UDI
- GMDN Term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Assufil Monofilamento by Assut Europe Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
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Cleared under the same submission
K150553 also covers:
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
- ASSUFIL MONOFILAMENTO — ASSUT EUROPE SPA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Assut Europe Spa
Sources (1)
- FDA UDI 443b0282-5b00-4bf5-b50f-3cdb187bf2f5 33 fields · synced Jun 8, 2026