Duns Number:006261481
Device Description: SUCTION 10062 TUBE MINI 20FR 20PK 17L
Catalog Number
-
Brand Name
DLP®
Version/Model Number
10062
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K950754,K950754
Product Code
GCY
Product Code Name
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Public Device Record Key
fb32ee2e-e106-481a-bbfd-b11a7bb188d8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 06, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |