Duns Number:190572854
Device Description: GII SNAP-PAK SNAP-PAK Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches GII SNAP-PAK SNAP-PAK Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with CP-2 needles
Catalog Number
216593
Brand Name
GII ETHIBOND
Version/Model Number
216593
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 28, 2021
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
-
Product Code
GAS
Product Code Name
Suture, nonabsorbable, synthetic, polyester
Public Device Record Key
cafb59d9-8d3d-42a2-a725-d1598ab12a5b
Public Version Date
September 27, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
20886705005373
Quantity per Package
5
Contains DI Package
10886705005376
Package Discontinue Date
January 28, 2021
Package Status
Not 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 | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |