Duns Number:190572854
Device Description: MICRO QUICKANCHOR Plus (Number 4/0) Suture 4/0 (1.5 metric) ORTHOCORD braided composite su MICRO QUICKANCHOR Plus (Number 4/0) Suture 4/0 (1.5 metric) ORTHOCORD braided composite suture, with C-1 taperpoint needles and a 1.3 x 5.0mm drill bit
Catalog Number
212041
Brand Name
QUICKANCHOR ORTHOCORD
Version/Model Number
212041
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
-
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
32fb8251-9b67-4046-af02-03281356942c
Public Version Date
March 21, 2019
Public Version Number
4
DI Record Publish Date
September 01, 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 | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |