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FDA product code OLL

Septal Stapler/Absorbable Staples

General, Plastic SurgeryClass 221 CFR 878.4750Implantable
US regulatory classifications
US Product Code (FDA)
OLL
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4750
Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction.

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About this record

Septal Stapler/Absorbable Staples 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.