Duns Number:315304071
Device Description: ACROMIONIZER Ø 5.5MM color code violet, PACK=5 PCS, WL 130mm, with lateral protection, fo ACROMIONIZER Ø 5.5MM color code violet, PACK=5 PCS, WL 130mm, with lateral protection, for use with motor handpieces M5/0 and M5/3, for extraction of bony structures, in Arthroscopy, sterile, for single use
Catalog Number
49975.0555
Brand Name
NA
Version/Model Number
499750555
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
Yes
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
HWE
Product Code Name
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Public Device Record Key
e4e1ae99-83ce-4b82-a54e-e33a034044c0
Public Version Date
February 25, 2022
Public Version Number
1
DI Record Publish Date
February 17, 2022
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 |