Duns Number:190572854
Device Description: FASTIN RC Anchor with ETHIBOND (1) Green (1) White strand Size 2 (5 metric) ETHIBOND braid FASTIN RC Anchor with ETHIBOND (1) Green (1) White strand Size 2 (5 metric) ETHIBOND braided polyester suture, 36 Inches (91cm), on disposable inserter.
Catalog Number
222720
Brand Name
FASTIN ETHIBOND
Version/Model Number
222720
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
K983818,K983818
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
ab6e49a4-6be3-4033-8d91-2f113cc93c8e
Public Version Date
March 21, 2019
Public Version Number
5
DI Record Publish Date
September 01, 2015
Package DI Number
20886705008220
Quantity per Package
5
Contains DI Package
10886705008223
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 | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |