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Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
General, Plastic Surgery Medical Device Type
Pure Global
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Regulatory Classifications

US Regulatory Classifications

PTX

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Class 2

21 CFR 878.4495

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General, Plastic Surgery

Device Characteristics

No

Yes

No

Not Eligible

Definition

This product code is the class II exempt counterpart of GAQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the ย“Physical Stateย” field of this product code description.