Duns Number:733853373
Device Description: The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended fo The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. 1.00 m long with a diameter of 2.00 mm
Catalog Number
7-AB1-001
Brand Name
Microblate Flex
Version/Model Number
AB1 Instrument
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
NEY
Product Code Name
System, Ablation, Microwave And Accessories
Public Device Record Key
3200404d-50c1-4472-9161-093597e1d67f
Public Version Date
August 06, 2021
Public Version Number
1
DI Record Publish Date
July 29, 2021
Package DI Number
05060359560193
Quantity per Package
5
Contains DI Package
05060359560209
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |