Duns Number:961027315
Device Description: Basic Pack
Catalog Number
9101
Brand Name
CONVERTORS
Version/Model Number
9101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 04, 2021
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRO
Product Code Name
General surgery tray (kit)
Public Device Record Key
24e84e1d-a166-4780-8ab0-93b4ce3a5fdf
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
June 28, 2016
Package DI Number
50630140166028
Quantity per Package
5
Contains DI Package
00630140029298
Package Discontinue Date
April 04, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |