Duns Number:315731711
Device Description: 3M™ Imprint™ 4 Preliminary Super Quick VPS Preliminary Impression Material Bulk Pack, 7154 3M™ Imprint™ 4 Preliminary Super Quick VPS Preliminary Impression Material Bulk Pack, 71549
Catalog Number
71549
Brand Name
3M™ Imprint™
Version/Model Number
71549
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
c7ad1182-5f2b-489f-99db-3b77092f6002
Public Version Date
August 10, 2022
Public Version Number
1
DI Record Publish Date
August 02, 2022
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 | 232 |
2 | A medical device with a moderate to high risk that requires special controls. | 563 |
U | Unclassified | 3 |