Duns Number:825137818
Device Description: SUTURE SYN ABS 3/8 NSF-2 4/0 18" DARBY
Catalog Number
9506238
Brand Name
Darby Dental Supply, LLC
Version/Model Number
VQ496-DAR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
4eed854c-1cd4-42b4-8009-ee47d0701d39
Public Version Date
December 10, 2018
Public Version Number
4
DI Record Publish Date
March 27, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1457 |
2 | A medical device with a moderate to high risk that requires special controls. | 194 |
U | Unclassified | 2 |