Duns Number:064783913
Device Description: "Used to contain instruments during ultrasonic and sterilization proceduresDurable, self-l "Used to contain instruments during ultrasonic and sterilization proceduresDurable, self-lubricating plastic with a securely snapping lidDimensions: 8-1/8"" x 1-7/8"" x 1-7/8""Contains Antimicrobial ProtectionAutoclavable up to 136°C/275F°Washer-disinfect"
Catalog Number
-
Brand Name
Steri-Container Neon Purple
Version/Model Number
50Z900R-BEN
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
-
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
-
Product Code
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
612e492c-5c5d-4966-8b16-1f52aba331fe
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 399 |