Duns Number:109903521
Device Description: SMARTSTITCH PERFECTPASSER SUTURE CARTRID
Catalog Number
OM-8178
Brand Name
SMARTSTITCH PERFECTPASSER
Version/Model Number
OM-8178
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
K123268,K123268
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
549e5e05-4c08-441c-92dd-748d56ffbe02
Public Version Date
February 11, 2022
Public Version Number
6
DI Record Publish Date
September 21, 2015
Package DI Number
20817470005848
Quantity per Package
6
Contains DI Package
00817470005844
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 |