Duns Number:039576871
Device Description: MICROSURGICAL GRID BACKGROUND MATERIAL WITHOUT SUCTION, SMOOTH - BLUE
Catalog Number
3105-S
Brand Name
MICROMAT®
Version/Model Number
3105-S
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
-
Product Code
FNW
Product Code Name
Pad, Kelly
Public Device Record Key
8d94c106-d291-4014-bbc1-febdd867f40d
Public Version Date
May 23, 2018
Public Version Number
3
DI Record Publish Date
August 01, 2016
Package DI Number
00650551037842
Quantity per Package
12
Contains DI Package
00650551037835
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |