Duns Number:807613393
Device Description: EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healin EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.
Catalog Number
1417151
Brand Name
EpiDisc TM Perf Patch Kit
Version/Model Number
653-160
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K982870,K982870
Product Code
KHJ
Product Code Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Public Device Record Key
15883cb9-1478-41d3-8d40-b4ba73b76863
Public Version Date
January 23, 2020
Public Version Number
1
DI Record Publish Date
January 15, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| 3 | A medical device with high risk that requires premarket approval | 15 |