Duns Number:167450993
Device Description: Accelerator III 4mm x 26cm Syringe Cannula
Catalog Number
III426-SYR
Brand Name
Accelerator III 4mm x 26cm Syringe Cannula
Version/Model Number
III426-SYR
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
-
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
K981172
Product Code
MUU
Product Code Name
System, suction, lipoplasty
Public Device Record Key
86ee0727-bbfc-4cfb-91e9-bfd5bdb71854
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
September 23, 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 | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 128 |
3 | A medical device with high risk that requires premarket approval | 545 |
U | Unclassified | 514 |