Duns Number:879187821
Device Description: COLT® Automatic guillotine type instrument for soft tissue biopsy, 14G x 11cm
Catalog Number
R-CLT1411
Brand Name
RELI
Version/Model Number
R-CLT1411
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
K051506,K051506
Product Code
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
68bd9208-4dc9-47b6-b5e8-ff59d134c01c
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
September 11, 2018
Package DI Number
10386120008087
Quantity per Package
10
Contains DI Package
00386120008080
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 471 |