Duns Number:025460908
Device Description: TOTE SB KARIN JWIRE LUMPECTOMY
Catalog Number
DYKM1802B
Brand Name
MEDLINE
Version/Model Number
DYKM1802B
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
08068ea4-d193-4259-985f-071ad358aa08
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
January 04, 2021
Package DI Number
20193489199106
Quantity per Package
1
Contains DI Package
10193489199109
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 |