Duns Number:134614411
Device Description: Sterile (15.3 x 244cm) polyethylene accordion-folded cover with attached form-fitting late Sterile (15.3 x 244cm) polyethylene accordion-folded cover with attached form-fitting latex tip
Catalog Number
645-058
Brand Name
T-Shaped Surgi Transducer Cover
Version/Model Number
645-058
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)
Yes
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
K943393,K943393
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
a10db6e4-fa6c-4701-9e19-ed3eee5a7ea4
Public Version Date
September 06, 2021
Public Version Number
5
DI Record Publish Date
August 22, 2017
Package DI Number
00841436106009
Quantity per Package
12
Contains DI Package
10841436106006
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 |