Duns Number:025460908
Device Description: LOCAL PACK
Catalog Number
DYNJ81709A
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJ81709A
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTN
Product Code Name
Plastic surgery and accessories kit
Public Device Record Key
278470b6-8798-4b77-bb03-a97b0f9350d3
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 04, 2022
Package DI Number
40195327238842
Quantity per Package
10
Contains DI Package
10195327238841
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 |