Duns Number:243880700
Device Description: "Vascular Silicone Ties, Radio Opaque, Sterile, Extra Mini-Blue, 0.040"" x 16"" / 0.1cm x "Vascular Silicone Ties, Radio Opaque, Sterile, Extra Mini-Blue, 0.040"" x 16"" / 0.1cm x 40 cm"
Catalog Number
10-1101
Brand Name
Batrik Vascular Silicones Ties, X-Mini Blue
Version/Model Number
10-1101
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
94b2006a-28f8-4e6c-bed1-1da37b9406bd
Public Version Date
December 24, 2021
Public Version Number
1
DI Record Publish Date
December 16, 2021
Package DI Number
00690521004207
Quantity per Package
10
Contains DI Package
00690521014084
Package Discontinue Date
-
Package Status
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 | 748 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |