Duns Number:315304071
Device Description: PERFORATED BASKET FOR PAIN THERAPY Holds: instrument set for pain therapy, for sterilizat PERFORATED BASKET FOR PAIN THERAPY Holds: instrument set for pain therapy, for sterilization (steam and low-temperature), storage and transport, with instrument holders, inner dimensions (wxhxd): 503x72x246mm, outer dimensions (wxhxd): 525x95x255mm
Catalog Number
33014
Brand Name
NA
Version/Model Number
33014
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
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
bc0fb4e1-ae37-4128-a0e2-e63faf30db5f
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 |