Duns Number:281906511
Device Description: WOLKMANN CURETTE 28 CM LARGE 10MM
Catalog Number
R12339M
Brand Name
OURY-GUYE & FILS
Version/Model Number
A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2050
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
c2cb7c1f-2486-41da-b56b-1775399be199
Public Version Date
April 14, 2022
Public Version Number
1
DI Record Publish Date
April 06, 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 | 21 |