Duns Number:025460908
Device Description: GUIDEWIRE, 0.032' X 60 CM, STRAIGHT TIP,
Catalog Number
GW3260I
Brand Name
MEDLINE
Version/Model Number
GW3260I
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
FOZ
Product Code Name
Catheter, intravascular, therapeutic, short-term less than 30 days
Public Device Record Key
be79000d-e0ef-4a58-bb37-ab4d00a06ff5
Public Version Date
December 24, 2021
Public Version Number
1
DI Record Publish Date
December 16, 2021
Package DI Number
10653160349549
Quantity per Package
10
Contains DI Package
20653160349546
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 |