Duns Number:812762226
Device Description: Onasorb 2 arm(s), 2xHLZL-5,5-200 10/0 30 cm PGA violet
Catalog Number
ON415595
Brand Name
Onatec
Version/Model Number
ON415595
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)
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
78524819-a669-4c18-9dc7-6d4a5bc5588d
Public Version Date
May 05, 2022
Public Version Number
1
DI Record Publish Date
April 27, 2022
Package DI Number
10848782005182
Quantity per Package
12
Contains DI Package
00848782005185
Package Discontinue Date
-
Package Status
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 | 300 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2030 |
| U | Unclassified | 19 |