Duns Number:315304071
Device Description: RESECTOR CONVEX CURVED SMOOTH Ø 5.5MM color code canary yellow, PACK=5 PCS, WL 130mm, for RESECTOR CONVEX CURVED SMOOTH Ø 5.5MM color code canary yellow, PACK=5 PCS, WL 130mm, for use with motor handpieces M5/0 and M5/3, for soft tissue extraction, in Arthroscopy, sterile, for single use
Catalog Number
49975.0255
Brand Name
NA
Version/Model Number
499750255
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
33b37b54-7fb7-4dd4-b1f0-1f7017ab1e22
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 |