Duns Number:005473608
Device Description: EXAFLEX® Monophase (purple) Clinic Packs (20 x 74mL base, 20 x 74mL catalyst)
Catalog Number
138420
Brand Name
EXAFLEX®
Version/Model Number
138420
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
K955932,K955932
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
1957609f-70f0-46db-8961-cc77a022812e
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 2022
Package DI Number
20386040006016
Quantity per Package
12
Contains DI Package
10386040006026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |