Duns Number:025460908
Device Description: GEL,ULTRASOUND,BOTTLE,8.5-OZ,CLEAR
Catalog Number
CTR001305
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
CTR001305
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"
Yes
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
K101952,K101952
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
18419045-577a-45cc-bc58-a6eb0afe3c60
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 24, 2021
Package DI Number
10035135013059
Quantity per Package
12
Contains DI Package
00035135013052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |