Duns Number:007941230
Device Description: Scalpel Surgical Safety Retractable Blade Stainless Steel Size 10 Disposable Sterile Not M Scalpel Surgical Safety Retractable Blade Stainless Steel Size 10 Disposable Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
SCPL10
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GES
Product Code Name
BLADE, SCALPEL
Public Device Record Key
4762046e-e065-479d-a1b7-07ca3527192c
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2020
Package DI Number
50885632133662
Quantity per Package
50
Contains DI Package
30885632133668
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 |