Duns Number:101497568
Device Description: SUTURE 5-0 NYLON 18"/DS-16 PROME
Catalog Number
BN65C
Brand Name
HAVEL'S
Version/Model Number
SUT 5-0 NYLON 18"/DS-16 PROME
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
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
d9e082dd-bb8d-4111-aa1c-8254bef5d976
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
June 16, 2016
Package DI Number
B070BN65C1
Quantity per Package
12
Contains DI Package
B070BN65C0
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. | 24 |