Duns Number:080194935
Device Description: Basik PGC SUTURE USP 3/0..3/8 REV CUTTING NEEDLE 24MM LENGTH One Device
Catalog Number
-
Brand Name
Bioviva-3D Dental
Version/Model Number
BPGC942
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
K130737,K130737,K130737
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
19e514ee-5312-4c77-b50e-8db3214b0aaf
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
December 15, 2016
Package DI Number
00817169021001
Quantity per Package
12
Contains DI Package
00817169021131
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |
| U | Unclassified | 1 |