Duns Number:058311945
Device Description: SPECIALTY TRIATHLON MIS PEGGED BOX GUIDE SIZE 1
Catalog Number
I-K2535BG01
Brand Name
INSTRUMENT
Version/Model Number
I-K2535BG01
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"
-
For Single-Use
-
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
HRY
Product Code Name
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Public Device Record Key
aa23d035-7183-4988-8359-202b920cb995
Public Version Date
June 24, 2019
Public Version Number
1
DI Record Publish Date
June 14, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5091 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10216 |
| 3 | A medical device with high risk that requires premarket approval | 32 |