Duns Number:179135769
Device Description: Low-Profile Back Plate (part of item 1435)
Catalog Number
1437
Brand Name
Accu-Cut® SRM™ 200
Version/Model Number
1437
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
IDO
Product Code Name
MICROTOME, ROTARY
Public Device Record Key
86ad99c8-9cfa-4be4-a6ed-57b2b9a31589
Public Version Date
August 20, 2020
Public Version Number
3
DI Record Publish Date
March 31, 2020
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 | 733 |