Duns Number:530269083
Device Description: New handle, Alligator, with spike, Single outer sheath, PE coated, Four-bar linkage, 2. New handle, Alligator, with spike, Single outer sheath, PE coated, Four-bar linkage, 2.3*1800 mm , 25 pcs in the box
Catalog Number
-
Brand Name
MT
Version/Model Number
NBF13-11123180
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCL
Product Code Name
Forceps, Biopsy, Non-Electric
Public Device Record Key
b2a89b98-9719-4954-9d41-66488ae9bdcf
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
December 31, 2021
Package DI Number
56932503540228
Quantity per Package
25
Contains DI Package
46932503540221
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |