Duns Number:859961950
Device Description: Sterile Infinity Loop Parcus Braid 5 w/ Needle
Catalog Number
20060
Brand Name
Parcus Braid
Version/Model Number
20060
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K100006,K100006
Product Code
GAT
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Public Device Record Key
540055fe-7b1c-44a3-a526-1840f138433e
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
November 17, 2015
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 399 |