Duns Number:118744421
Device Description: Surgical Isolation Gown AAMI LV2, 25g SMMS, Yellow, XL
Catalog Number
SG003
Brand Name
CALICO
Version/Model Number
SG003
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212357,K212357,K212357
Product Code
FYC
Product Code Name
Gown, Isolation, Surgical
Public Device Record Key
26a683b7-4003-4264-8fe3-bb142e890baf
Public Version Date
September 14, 2022
Public Version Number
1
DI Record Publish Date
September 06, 2022
Package DI Number
20850044458817
Quantity per Package
10
Contains DI Package
00850044458813
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |