Duns Number:298725490
Device Description: Silicone rubber sheet
Catalog Number
SRS6A(29)
Brand Name
EXMOOR
Version/Model Number
SRS.6a(29)
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
K911503,K911503
Product Code
KHJ
Product Code Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Public Device Record Key
5620bcda-a2f1-49a7-84ba-75581813363a
Public Version Date
October 15, 2019
Public Version Number
2
DI Record Publish Date
September 21, 2018
Package DI Number
05060180254612
Quantity per Package
20
Contains DI Package
05060180252106
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
a box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 245 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |