Duns Number:039576871
Device Description: TE CRESCENT, SMOOTH SURFACE, TWO STAGE, REMOTE PORT, 4X6CM, 97CC FILL, 6CM PROJECTION
Catalog Number
3614-550-2
Brand Name
Integra
Version/Model Number
3614-550-2
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
5dcad5cb-c22b-4ad0-b8d1-f4ba978c4a22
Public Version Date
December 19, 2019
Public Version Number
1
DI Record Publish Date
December 11, 2019
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 |