Duns Number:134614411
Device Description: Sterile 18GA grid for use with AccuCARE Positioning and Stabilizing equipment
Catalog Number
610-906, H46222LH
Brand Name
Template Grid
Version/Model Number
610-906, H46222LH
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
K131161,K131161,K131161
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
2eed66c8-9126-4345-8516-2c75d2813b07
Public Version Date
August 23, 2022
Public Version Number
5
DI Record Publish Date
August 22, 2017
Package DI Number
00841436104364
Quantity per Package
5
Contains DI Package
10841436104361
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 |