Duns Number:109903521
Device Description: HEALICOIL PK 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE SU HEALICOIL PK 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE BLUE AND ONE ULTRABRAID SUTURE No.2
Catalog Number
72203983
Brand Name
HEALICOIL
Version/Model Number
72203983
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K113294
Product Code
MBI
Product Code Name
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Public Device Record Key
9f87ef94-ee13-4283-ae0f-50b3dbb1b1b7
Public Version Date
October 09, 2020
Public Version Number
6
DI Record Publish Date
October 22, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |