Duns Number:058614483
Device Description: Chronic Catheter Accessory,Oval Pull Apart Introducer Set
Catalog Number
8815544013
Brand Name
Argyle
Version/Model Number
8815544013
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
K873394,K873394
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
7fec3844-2d13-4861-b6b3-bf4cd9a0db88
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20884521024332
Quantity per Package
5
Contains DI Package
10884521024335
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |