Duns Number:530269083
Device Description: Alligator, without spike, 2.3*1800 mm
Catalog Number
-
Brand Name
MT
Version/Model Number
HBF65-11023180
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
K180018,K180018,K180018
Product Code
KGE
Product Code Name
Forceps, Biopsy, Electric
Public Device Record Key
d1a415ce-f2d1-4ba6-a05e-708c87fb2715
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
December 31, 2021
Package DI Number
16932503548530
Quantity per Package
10
Contains DI Package
06932503548533
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 |