Duns Number:023055619
Device Description: Scanlan® Micro Forceps Round Lightweight handle 1 mm 45° angled DeBakey tips. 8 1/4" / 21 Scanlan® Micro Forceps Round Lightweight handle 1 mm 45° angled DeBakey tips. 8 1/4" / 21 cm
Catalog Number
4004-232A
Brand Name
SCANLAN® Forceps
Version/Model Number
4004-232A
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
GEN
Product Code Name
Forceps, General & Plastic Surgery
Public Device Record Key
7752e1c9-be87-4fd6-b264-25df794ec64e
Public Version Date
November 28, 2019
Public Version Number
1
DI Record Publish Date
November 20, 2019
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 | 1949 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 855 |