Duns Number:051798999
Device Description: ProLoop Mesh M, 1.3in. x 1.8in. (3.3cm x 4.6cm), 1.55in. (3.9cm), 3.5in. (8.9cm)
Catalog Number
-
Brand Name
PROLOOP
Version/Model Number
30901
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151437,K930669,K151437,K930669
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
78096de4-cc1f-4e07-9d69-d0eebb6b981f
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
September 24, 2015
Package DI Number
20650862309014
Quantity per Package
2
Contains DI Package
00650862309010
Package Discontinue Date
December 31, 2019
Package Status
Not 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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |