Duns Number:482661753
Device Description: ORTHOCORD One Violet and One Blue Braided Composite Suture MO-7 22 mm 1/2c,Taper N=2 Meets ORTHOCORD One Violet and One Blue Braided Composite Suture MO-7 22 mm 1/2c,Taper N=2 Meets U.S.P. and E.P. except for diameter 2 (5 metric), 36 Inches (91 cm)
Catalog Number
223114
Brand Name
ORTHOCORD
Version/Model Number
223114
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
K043298,K043298
Product Code
NEW
Product Code Name
SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
Public Device Record Key
df8bab3f-516a-4bd2-9ca8-09146f7c5abd
Public Version Date
July 23, 2021
Public Version Number
7
DI Record Publish Date
September 01, 2015
Package DI Number
20886705008848
Quantity per Package
12
Contains DI Package
10886705008841
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACKAGE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |