Duns Number:256880576
Device Description: MEDICOM SAFETOUCH DENTAL DAM 6 X 6 Inch
Catalog Number
1266HG
Brand Name
MEDICOM SAFETOUCH
Version/Model Number
1266HG
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIE
Product Code Name
DAM, RUBBER
Public Device Record Key
d6a30966-8c74-4c8d-8eed-91cde998fbdd
Public Version Date
February 18, 2019
Public Version Number
1
DI Record Publish Date
January 16, 2019
Package DI Number
20686864047432
Quantity per Package
6
Contains DI Package
10686864047435
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |