Duns Number:832696038
Device Description: GUILFORD-WRIGHT MICRO BONE CURETTE, 1.5 X 2.6MM ANGLED OVAL CUP OVERALL LENGTH 5-1/8"(13CM GUILFORD-WRIGHT MICRO BONE CURETTE, 1.5 X 2.6MM ANGLED OVAL CUP OVERALL LENGTH 5-1/8"(13CM)
Catalog Number
AU13338
Brand Name
V. Mueller
Version/Model Number
AU13338
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JYG
Product Code Name
CURETTE, EAR
Public Device Record Key
09bf4bca-d2b9-4d39-bba4-ac49e755e8ff
Public Version Date
April 21, 2021
Public Version Number
3
DI Record Publish Date
July 13, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |