← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS I

PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin

DEVICE CLASS
Class I
REGULATION
21 CFR 880.5240
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
SU
ImplantLife-sustainingGMP-exemptThird-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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