Duns Number:530269083
Device Description: Normal handle, Oval, without spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 Normal handle, Oval, without spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 mm
Catalog Number
100578
Brand Name
MT
Version/Model Number
100578
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
26a30014-c5eb-420c-953d-3f9663b90ddb
Public Version Date
March 31, 2020
Public Version Number
1
DI Record Publish Date
March 23, 2020
Package DI Number
16932503540381
Quantity per Package
10
Contains DI Package
06932503540384
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 |