Duns Number:256880576
Device Description: MEDICOM SAFEBASICS BOUFFANT CAP 21 Inch
Catalog Number
8000
Brand Name
MEDICOM SAFEBASICS
Version/Model Number
8000
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
FYF
Product Code Name
CAP, SURGICAL
Public Device Record Key
96b1d6f7-e3a7-47c1-8b27-b1a5c6b852e7
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
January 13, 2019
Package DI Number
20686864049351
Quantity per Package
5
Contains DI Package
10686864049354
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 |