Duns Number:006261481
Device Description: ACCESSORY 2872 ADPTR IMPL BIP LD
Catalog Number
-
Brand Name
NA
Version/Model Number
2872
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 07, 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
K982220
Product Code
DTD
Product Code Name
pacemaker lead Adaptor
Public Device Record Key
f511a6ad-68e0-4704-8b90-7c8a7eece6fc
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
June 10, 2015
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 |