Duns Number:005449822
Device Description: Custom Finish (SP-XXXX)
Catalog Number
-
Brand Name
ZOLL-DENTAL
Version/Model Number
IP-SP
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIL
Product Code Name
GAUGE, DEPTH, INSTRUMENT, DENTAL
Public Device Record Key
f5d0fad7-cbb3-48d4-96b0-92fda3bac75c
Public Version Date
November 18, 2021
Public Version Number
3
DI Record Publish Date
January 17, 2020
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 | 2197 |