Duns Number:190572854
Device Description: OMNISPAN MENISCAL REPAIR SYSTEM / 27 Degrees ORTHOCORD Violet braided composite suture, Si OMNISPAN MENISCAL REPAIR SYSTEM / 27 Degrees ORTHOCORD Violet braided composite suture, Size 2-0, (2) PEEK Backstops, and 27 Degrees (1) Curved Needle
Catalog Number
228142
Brand Name
OMNISPAN ORTHOCORD
Version/Model Number
228142
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
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
K092836
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
a5039766-4826-42c8-abef-bf7d1cf55c49
Public Version Date
March 21, 2019
Public Version Number
5
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 |