Duns Number:103169095
Device Description: SingleCycle Disposable Instrument Tray (O.Dim. 15.25 X 18.85 x 3.0, I.Dim. 13.13 x 7.13 x SingleCycle Disposable Instrument Tray (O.Dim. 15.25 X 18.85 x 3.0, I.Dim. 13.13 x 7.13 x 2.75) with Soiled Instrument Sticker - 60 Trays & 60 Stickers
Catalog Number
-
Brand Name
SingleCycle Disposable Instrument Tray with Soiled Instrument Sticker
Version/Model Number
IT0713-SI
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
-
Product Code
PXV
Product Code Name
General Purpose Instrument Tray
Public Device Record Key
b8263f16-272f-4451-9904-e3492b932c91
Public Version Date
February 08, 2022
Public Version Number
1
DI Record Publish Date
January 31, 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 | 146 |