Duns Number:204112346
Device Description: The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that fac The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumable set consists of a Specimen Tray and Specimen Lid. The Specimen Tray engages with the device to initiate scanning and the Specimen Lid facilitates engaging vacuum to enable vacuum assisted specimen positioning during image acquisition.
Catalog Number
ASY-2600
Brand Name
Specimen Immobilizer
Version/Model Number
PMI010CON21
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203578,K203578,K203578
Product Code
NQQ
Product Code Name
System, Imaging, Optical Coherence Tomography (Oct)
Public Device Record Key
cee9428c-b7ab-4c2d-a8ad-43c52c73fb89
Public Version Date
September 07, 2021
Public Version Number
1
DI Record Publish Date
August 30, 2021
Package DI Number
20754016215029
Quantity per Package
10
Contains DI Package
00754016215025
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10 pck consumables