Duns Number:947451626
Device Description: Instrument Tray 576 mm x 270 mm x 100 mm (22-11/16 in x 10-5/8 in x 4 in)
Catalog Number
13837
Brand Name
Aptimax
Version/Model Number
13837
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013003,K013003
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
bdd23bf8-3ee6-4d39-a80a-f8507581643d
Public Version Date
September 16, 2022
Public Version Number
9
DI Record Publish Date
September 24, 2016
Package DI Number
20705037016126
Quantity per Package
2
Contains DI Package
10705037016129
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 | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 159 |