Duns Number:002348191
Device Description: Hi-Fi Blue Size 2 40" & White/Black Co-Braid Size 2 40" HC-5 Needle ConMed
Catalog Number
H6210T
Brand Name
HI-FI
Version/Model Number
IPN001163
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
6dd74a88-cb83-4a38-bcf9-f8b406d2e653
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
January 17, 2019
Package DI Number
34026704604129
Quantity per Package
12
Contains DI Package
44026704604126
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 |