Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
The non-sterile corrugated rubber sheath for non-indwelling catheters is a urological device used as an external catheter accessory, providing a flexible connection between the penis and a urine collection system. It is classified as FDA Class 1 under regulation 876.5250 in the Gastroenterology and Urology specialty, and it is GMP exempt. Product code NNY does not require a 510(k) submission and is associated with product code EYT.
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Basic Information
- Product Code
- NNY
- Device Class
- FDA class 1
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
Definition
Urine collector and accessories; see product code EYT.
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.