Duns Number:481542926
Device Description: SDC-18R-8-2R-SF, dissecting scissors by Blondeel, 18 cm long, round, curved with 2 ring gr SDC-18R-8-2R-SF, dissecting scissors by Blondeel, 18 cm long, round, curved with 2 ring grips, SUPERFINE
Catalog Number
00943
Brand Name
NA
Version/Model Number
SDC-18R-8-2R-SF
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
LRW
Product Code Name
Scissors, General, Surgical
Public Device Record Key
efc98a4b-db1f-4b9b-a681-8bee126055f6
Public Version Date
September 23, 2022
Public Version Number
1
DI Record Publish Date
September 15, 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 | 306 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |