FDA product code NHB

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Ear, Nose, Throat·Class 2·21 CFR 874.3620
US regulatory classifications
US Product Code (FDA)
NHB
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 874.3620
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Medical specialty
Ear, Nose, Throat
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.

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About this record

Polymer, Ear, Nose And Throat, Synthetic, Absorbable is a medical device type in the Ear, Nose, Throat 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.

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.