Duns Number:025460908
Device Description: SYR CONTROL 8ML ROTATING
Catalog Number
DNSC89369
Brand Name
Medline Industries, Inc.
Version/Model Number
DNSC89369
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
K170025,K170025
Product Code
DXT
Product Code Name
Injector and syringe, angiographic
Public Device Record Key
ccf448c1-37c2-430d-be78-c48744326dfb
Public Version Date
August 12, 2022
Public Version Number
1
DI Record Publish Date
August 04, 2022
Package DI Number
40889942596226
Quantity per Package
150
Contains DI Package
10889942596225
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 |