Duns Number:603420183
Device Description: TK® Ti-KNOT® DEVICEEach sterile package contains (1) single patient use disposable TITANIU TK® Ti-KNOT® DEVICEEach sterile package contains (1) single patient use disposable TITANIUM KNOT® placement device. Base Package Type - Each
Catalog Number
030404
Brand Name
TK® Ti-KNOT® DEVICE
Version/Model Number
030404
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
-
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
K100593,K100593
Product Code
HCF
Product Code Name
Instrument, Ligature Passing And Knot Tying
Public Device Record Key
f25d2234-6b51-479b-9dfa-a9f87b8c08d9
Public Version Date
July 16, 2020
Public Version Number
4
DI Record Publish Date
May 12, 2016
Package DI Number
10850200006091
Quantity per Package
6
Contains DI Package
00850200006094
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 56 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |