Duns Number:083171244
Device Description: INTEGRA Meshed Dermal Regeneration Template 4in. x 10in. (10cm x 25cm), an Integra templat
Catalog Number
MDRT4101
Brand Name
INTEGRA®
Version/Model Number
MDRT4101
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"
Yes
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
P900033
Product Code
MDD
Product Code Name
DEVICE, DERMAL REPLACEMENT
Public Device Record Key
69479c87-abbb-42be-8729-22ec2f732ef3
Public Version Date
October 25, 2022
Public Version Number
7
DI Record Publish Date
September 05, 2014
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 | 14 |
2 | A medical device with a moderate to high risk that requires special controls. | 75 |
3 | A medical device with high risk that requires premarket approval | 17 |
U | Unclassified | 32 |