Duns Number:051798999
Device Description: ProLoop Mesh XL, 1.6in. x 1.8in. (4.1cm x 4.6cm), 2.0in. (5.0cm), 3.5in. (8.9cm)
Catalog Number
-
Brand Name
PROLOOP
Version/Model Number
30903
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
604a8cf8-9f65-4135-82ae-888c3695c3c7
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
September 24, 2015
Package DI Number
20650862309038
Quantity per Package
2
Contains DI Package
00650862309034
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 |