Duns Number:025460908
Device Description: UNIVERSAL BLOCK TRAY-LF
Catalog Number
DYNJRA0445
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJRA0445
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
OGJ
Product Code Name
Nerve block tray
Public Device Record Key
46b068a0-42fb-4eb8-b652-b446182ce0bf
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
November 07, 2016
Package DI Number
40884389778037
Quantity per Package
20
Contains DI Package
10884389778036
Package Discontinue Date
-
Package Status
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |