Duns Number:039576871
Device Description: INTEGRA, RECTANGLE SHAPE, ENHANCED SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER WITH INTEGRA, RECTANGLE SHAPE, ENHANCED SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER WITH SUTURE TABS
Catalog Number
-
Brand Name
INTEGRA
Version/Model Number
3610ES-58-ST
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K845036
Product Code
LCJ
Product Code Name
Expander, Skin, Inflatable
Public Device Record Key
d928a68b-41b9-46da-b9f4-8f5ab322d627
Public Version Date
August 25, 2020
Public Version Number
1
DI Record Publish Date
August 17, 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 | 673 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8273 |
| U | Unclassified | 1188 |