Duns Number:196548481
Device Description: + READER COVER
Catalog Number
0694-002-006
Brand Name
SURGICOUNT
Version/Model Number
0694002006
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
-
Product Code
LWH
Product Code Name
Counter, sponge, surgical
Public Device Record Key
dfd9b2e7-b714-4cc1-b60d-559cc0b06d05
Public Version Date
July 16, 2021
Public Version Number
1
DI Record Publish Date
July 08, 2021
Package DI Number
57613327517977
Quantity per Package
9
Contains DI Package
37613327517973
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 | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |