Duns Number:488227125
Device Description: MectaLock All-Suture Anchor Size 1 – Short – 2x USP#2
Catalog Number
-
Brand Name
MectaLock All-Suture Anchor
Version/Model Number
05.11.010
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
K193461
Product Code
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
f0122339-845c-4797-a80d-9a8e1df04595
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
February 10, 2020
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 | 8200 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9084 |