Duns Number:006261481
Device Description: WIRE 008437 10PK BH .035 145 TEF CTD SG
Catalog Number
-
Brand Name
Angiographic Guide Wire
Version/Model Number
008437
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 2019
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
K082873,K082873
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
20b2dc73-58b6-4b3a-b4aa-223949cf2c94
Public Version Date
September 22, 2022
Public Version Number
4
DI Record Publish Date
May 19, 2017
Package DI Number
20643169857029
Quantity per Package
10
Contains DI Package
00643169857025
Package Discontinue Date
October 21, 2019
Package Status
Not in Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |