Duns Number:025460908
Device Description: DEACONESS MINI LAP PACK
Catalog Number
DYNJ42243
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJ42243
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
FDE
Product Code Name
laparoscopy kit
Public Device Record Key
52bf0837-1b64-4ee2-b5a0-745498f2e035
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
September 29, 2016
Package DI Number
40884389920351
Quantity per Package
4
Contains DI Package
10884389920350
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 |