Duns Number:243880700
Device Description: Vascular Silicone Ties, Radio Opaque, Sterile, Maxi-Red, 0.120" x 16" / 0.3cm x 40 cm
Catalog Number
10-1010
Brand Name
Batrik Vascular Silicone Ties
Version/Model Number
10-1010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCF
Product Code Name
Instrument, Ligature Passing And Knot Tying
Public Device Record Key
b5830e8a-c286-42cf-a250-9f55c151cebf
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 2020
Package DI Number
00690521004061
Quantity per Package
10
Contains DI Package
00690521014046
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 | 748 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |