Duns Number:025460908
Device Description: HEAD AND NECK PACK
Catalog Number
DYNJ30245
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJ30245
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
OGR
Product Code Name
Ear, nose, and throat surgical tray
Public Device Record Key
224129d7-b13f-450e-8249-7d1a55b9f7ef
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
July 16, 2021
Package DI Number
40080196787693
Quantity per Package
3
Contains DI Package
10080196787692
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 |