Duns Number:081290972
Device Description: SMITH Wire cutting scissor with TC 16 cm. Straight
Catalog Number
-
Brand Name
FAICO CMF System
Version/Model Number
F1.2-84416
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)
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
c90ff120-aebf-49b8-b8c9-e62e3f2420af
Public Version Date
April 26, 2021
Public Version Number
1
DI Record Publish Date
April 17, 2021
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 | 425 |
2 | A medical device with a moderate to high risk that requires special controls. | 1392 |