Duns Number:134614411
Device Description: Sterile 17GA grid (10), sterile (81.3 x 91.4cm) polyethylene drape (10), non-sterile (2 x Sterile 17GA grid (10), sterile (81.3 x 91.4cm) polyethylene drape (10), non-sterile (2 x 14cm) endocavity balloon (10) and sterile Aquasonic 20 gel packettes (10)
Catalog Number
610-1294
Brand Name
AccuCARE Accessory Kit
Version/Model Number
610-1294
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 07, 2022
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
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,K970513,K992152
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
b9dfe822-5f14-4f2c-aa9f-d849521539f7
Public Version Date
August 23, 2022
Public Version Number
5
DI Record Publish Date
August 22, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |