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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wound dressing kit
Regulation Description Elastic bandage.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeMCY
Regulation Number 880.5075
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 2 2
Contamination /Decontamination Problem 2 2
Insufficient Information 2 2
Patient-Device Incompatibility 1 1
Adhesive 1 1
Physical Resistance/Sticking 1 1
Biocompatibility 1 1
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abrasion 2 2
No Known Impact Or Consequence To Patient 2 2
Unspecified Infection 2 2
Reaction 1 1
No Information 1 1
No Code Available 1 1
Blister 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Apr-14-2016
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