Duns Number:627879687
Device Description: The Histolock resection kit (5-piece) contains the devices needed for injecting, resecting The Histolock resection kit (5-piece) contains the devices needed for injecting, resecting, and collecting flat lesions. The kit is made up of the Histolock Resection Device, Carr-Locke injection needle, eTrap polyp trap and Mio medical device organizer.
Catalog Number
00711873
Brand Name
Histolock
Version/Model Number
00711873
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
-
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
K122462,K140763,K971842,K122462,K140763,K971842
Product Code
FCG
Product Code Name
Biopsy needle
Public Device Record Key
16ae9a47-ed94-4b21-9a6d-e0c771fdbf22
Public Version Date
April 07, 2021
Public Version Number
7
DI Record Publish Date
September 17, 2016
Package DI Number
10816765012847
Quantity per Package
3
Contains DI Package
00816765012840
Package Discontinue Date
March 31, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |