Duns Number:763408366
Device Description: DISPOSABLE HORIZONTAL SCISSORS, 25G
Catalog Number
-
Brand Name
DISPOSABLE HORIZONTAL SCISSORS, 25G
Version/Model Number
S9.6014.25
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HNF
Product Code Name
Scissors, Ophthalmic
Public Device Record Key
107a55f6-8015-4624-8f20-f416fb72960a
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 29, 2021
Package DI Number
23700773721317
Quantity per Package
5
Contains DI Package
13700773721310
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 82 |
2 | A medical device with a moderate to high risk that requires special controls. | 291 |
U | Unclassified | 60 |