Duns Number:014464314
Device Description: Surgical Gown, XX Large, AAMI 4 HaloGuard
Catalog Number
E104070
Brand Name
Exact Medical Manufacturing Inc
Version/Model Number
E104070
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
K120045,K120045
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
0fe66cb2-dd7f-4fd7-a186-ca1ad991be86
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
April 09, 2020
Package DI Number
00850015378577
Quantity per Package
32
Contains DI Package
00850015378560
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 489 |