Duns Number:025460908
Device Description: INTRODUCER,STD, INTRO-FLEX 9F
Catalog Number
I305BF9A
Brand Name
MEDLINE
Version/Model Number
I305BF9A
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OFD
Product Code Name
Catheter introducer kit
Public Device Record Key
8134fbce-e46b-4ebd-9734-9667ccc67bc4
Public Version Date
May 31, 2021
Public Version Number
1
DI Record Publish Date
May 23, 2021
Package DI Number
00653160347142
Quantity per Package
10
Contains DI Package
10653160347149
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 |