Label Or Tag, Sterile
The Sterile Label or Tag (product code LYV) is a device consisting of labels or tags that have been sterilized, used to mark sterile surgical instruments, supplies, or packaging within the sterile field without compromising sterility. Regulated under 21 CFR 878.4800 and classified as a Class 1 device subject only to general controls, it falls under the General and Plastic Surgery specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.
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Basic Information
- Product Code
- LYV
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 73 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 74 registration numbers. Click on an entry to view related FDA registrations.