Duns Number:006261481
Device Description: INTRODUCER 693323 10PK 9F 23CM DILATOR
Catalog Number
-
Brand Name
NA
Version/Model Number
693323
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2018
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
K132617,K132617
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
edb6f3b2-e4da-4b58-b0a1-a871e560ccd2
Public Version Date
June 07, 2019
Public Version Number
5
DI Record Publish Date
February 03, 2017
Package DI Number
20643169115990
Quantity per Package
10
Contains DI Package
00643169115996
Package Discontinue Date
October 05, 2018
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 |