Duns Number:530269083
Device Description: Normal handle, Alligator, without spike, Single outer sheath, FEP coated, Two Wire, 2.3* Normal handle, Alligator, without spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 mm
Catalog Number
100576
Brand Name
MT
Version/Model Number
100576
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
d2325e72-b503-49e9-9931-d8ec2e9e3856
Public Version Date
March 31, 2020
Public Version Number
1
DI Record Publish Date
March 23, 2020
Package DI Number
16932503540367
Quantity per Package
10
Contains DI Package
06932503540360
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 |