Duns Number:038000253
Device Description: 0.018" (0.47MM) X 45CM0.018" (0. NITINOL GUIDEWIRENITINOL GUIDEWI W/RADIOPAQUE TIPW/RADIOP 0.018" (0.47MM) X 45CM0.018" (0. NITINOL GUIDEWIRENITINOL GUIDEWI W/RADIOPAQUE TIPW/RADIOPAQUE TIP
Catalog Number
-
Brand Name
MICRO STICK SETMICRO STICK SET
Version/Model Number
AAC19601
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 23, 2021
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
b3dc5484-5db1-4fc7-bb1f-7e41dfd567d7
Public Version Date
October 04, 2021
Public Version Number
3
DI Record Publish Date
December 21, 2017
Package DI Number
50884908000639
Quantity per Package
1
Contains DI Package
00884908000634
Package Discontinue Date
August 23, 2021
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |