Duns Number:007941230
Device Description: Scissor Operating Room Straight Blunt/Sharp Stainless Steel 5.5 Inch Not Made With Natural Scissor Operating Room Straight Blunt/Sharp Stainless Steel 5.5 Inch Not Made With Natural Rubber Latex Sterile MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
FG6001
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDC
Product Code Name
INSTRUMENT, SURGICAL, DISPOSABLE
Public Device Record Key
12e28562-99da-41c1-9344-8a4d9634d6d2
Public Version Date
September 23, 2022
Public Version Number
2
DI Record Publish Date
October 12, 2020
Package DI Number
50885632110564
Quantity per Package
25
Contains DI Package
10885632110566
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |