Duns Number:109903521
Device Description: SMARTSTITCH SUTURE CART.
Catalog Number
OM-8076
Brand Name
SMARTSTITCH M-CONNECTOR
Version/Model Number
OM-8076
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"
Yes
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
K123268,K123268
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
610b4b25-7dec-4e0d-bde7-e070b5b40177
Public Version Date
January 31, 2020
Public Version Number
4
DI Record Publish Date
September 21, 2015
Package DI Number
20817470007415
Quantity per Package
6
Contains DI Package
00817470007411
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
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 |