Duns Number:002348191
Device Description: Blue braided Size 2 K-61 N White braided 2 K-61 White/blue co-braid 2 White braided 5 HSCX Blue braided Size 2 K-61 N White braided 2 K-61 White/blue co-braid 2 White braided 5 HSCX48 N White/Blue co-braid 5 HSCX48 N White braided 5 MAXBRAID Biomet
Catalog Number
900314
Brand Name
TELEFLEX
Version/Model Number
IPN010322
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
d50a9281-197e-4454-b268-dc56237c7b54
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
March 18, 2020
Package DI Number
54026704582766
Quantity per Package
1
Contains DI Package
64026704582763
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |