Duns Number:071595540
Device Description: Infinity Suture Shuttle
Catalog Number
KSP100
Brand Name
Infinity
Version/Model Number
KSP100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 22, 2021
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"
-
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
6222e77d-97cc-4b0b-8523-ecedd880b7a5
Public Version Date
August 23, 2021
Public Version Number
3
DI Record Publish Date
April 15, 2020
Package DI Number
30845854902060
Quantity per Package
10
Contains DI Package
20845854902063
Package Discontinue Date
August 22, 2021
Package Status
Not in Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |