Duns Number:530269083
Device Description: Normal handle, Alligator, with spike, Single outer sheath, Uncoated, Two Wire, 2.3*2300 Normal handle, Alligator, with spike, Single outer sheath, Uncoated, Two Wire, 2.3*2300 mm
Catalog Number
100571
Brand Name
MT
Version/Model Number
100571
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
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
7f136bf3-c5db-4d7a-9a21-09e85e3d180e
Public Version Date
May 07, 2021
Public Version Number
2
DI Record Publish Date
March 23, 2020
Package DI Number
16932503540312
Quantity per Package
10
Contains DI Package
06932503540315
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 |