Duns Number:315018218
Device Description: ACCULAN II NICD BATTERY SHORT
Catalog Number
GA646
Brand Name
ACCULAN II
Version/Model Number
GA646
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 27, 2021
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
-
Product Code
MOQ
Product Code Name
BATTERY, REPLACEMENT, RECHARGEABLE
Public Device Record Key
205bef3c-54de-45d9-9b4a-8aac58076770
Public Version Date
May 28, 2021
Public Version Number
2
DI Record Publish Date
April 29, 2020
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 | 11840 |
2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
3 | A medical device with high risk that requires premarket approval | 37 |