Duns Number:006261481
Device Description: WIRE 010004 10PK .038 3MM J TC GWIRE LT
Catalog Number
-
Brand Name
Angiographic Guide Wire
Version/Model Number
010004
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
K082873,K082873
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
22485801-dee1-43e9-9a93-2a47c0eb1232
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 19, 2017
Package DI Number
20643169857234
Quantity per Package
10
Contains DI Package
00643169857230
Package Discontinue Date
-
Package Status
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 |