Duns Number:002348191
Device Description: Bondek Plus Violet Braided Polyglycolic Acid Size 0 48" Two FX45 Needles Bard
Catalog Number
BON200
Brand Name
BONDEK
Version/Model Number
IPN000887
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"
Yes
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
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
14300b5e-ed07-4574-b756-84c18ee6c984
Public Version Date
January 15, 2019
Public Version Number
3
DI Record Publish Date
October 16, 2015
Package DI Number
24026704604672
Quantity per Package
12
Contains DI Package
04026704604678
Package Discontinue Date
January 15, 2019
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |