Duns Number:625064352
Device Description: Apollo 2-0 Polypropylene Suture to be utilized with the OverStitch Endoscopic Suturing Sys Apollo 2-0 Polypropylene Suture to be utilized with the OverStitch Endoscopic Suturing System
Catalog Number
PLY-G02-020-APL
Brand Name
OverStitch Endoscopic Suturing System
Version/Model Number
PLY-G02-020-APL
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
K191439,K191439
Product Code
GAW
Product Code Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Public Device Record Key
944df80a-c131-4cb2-9572-24fd9b9b04c9
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
October 31, 2019
Package DI Number
10811955020732
Quantity per Package
12
Contains DI Package
00811955020735
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 34 |