Duns Number:256880576
Device Description: MEDICOM SAFEJET DISPOSABLE AIR/WATER SYRINGE TIPS - White
Catalog Number
1007074
Brand Name
MEDICOM SAFEJET
Version/Model Number
1007074
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECB
Product Code Name
Unit, Syringe, Air And/Or Water
Public Device Record Key
8f8d7132-d806-43c2-9d21-d6da41cb2b1d
Public Version Date
May 21, 2021
Public Version Number
1
DI Record Publish Date
May 13, 2021
Package DI Number
20686864057271
Quantity per Package
12
Contains DI Package
10686864057274
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 |