Duns Number:021628771
Device Description: Monofilament, nylon, 9”. These unique sutures are sized and priced for closing punch biops Monofilament, nylon, 9”. These unique sutures are sized and priced for closing punch biopsies and wounds only requiring two or three stitches. Black color.
Catalog Number
-
Brand Name
Delasco Biopsy Suture
Version/Model Number
BDL-60B
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
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
93e5735f-49fa-4ba2-a790-1cf95de71a2f
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
November 02, 2015
Package DI Number
20609960000033
Quantity per Package
84
Contains DI Package
10609960000036
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |