Duns Number:243880700
Device Description: "Suture Clamp Tags, Radio Opaque, Sterile, Blue, Standard ø 0.06"" x 0.5""L"
Catalog Number
11-1065
Brand Name
Batrik Suture Tags Blue 5 pairs
Version/Model Number
11-1065
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
KDC
Product Code Name
Instrument, Surgical, Disposable
Public Device Record Key
690f4c6d-c8d9-407f-bb6e-98874f5fa47d
Public Version Date
December 24, 2021
Public Version Number
1
DI Record Publish Date
December 16, 2021
Package DI Number
00690521004474
Quantity per Package
5
Contains DI Package
00690521014398
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 |