Duns Number:315304071
Device Description: MOTOR HANDPIECE MAX. 6000RPM connection cable 8564851 required, for use with rotation mor MOTOR HANDPIECE MAX. 6000RPM connection cable 8564851 required, for use with rotation morcellators, control by footswitch, reusable
Catalog Number
8564122
Brand Name
NA
Version/Model Number
8564122
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEY
Product Code Name
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Public Device Record Key
cc0dcd35-ca1c-4d1a-9857-8b65648712be
Public Version Date
May 24, 2021
Public Version Number
1
DI Record Publish Date
May 14, 2021
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |