Duns Number:134614411
Device Description: Sterile guide accepts 14GA instruments or 2.4mm therapeutic probes. For use with CIVCO Cla Sterile guide accepts 14GA instruments or 2.4mm therapeutic probes. For use with CIVCO Classic and Multi-Purpose Workstation™ Steppers
Catalog Number
610-977, H46222LP
Brand Name
Template Grid
Version/Model Number
610-977, H46222LP
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
K972672,K972672,K972672
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
c8f05956-da99-4333-b001-c32183a24405
Public Version Date
August 23, 2022
Public Version Number
5
DI Record Publish Date
August 22, 2017
Package DI Number
00841436104661
Quantity per Package
5
Contains DI Package
10841436104668
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |