Specimen Immobilizer ASY-2600

GUDID 20754016215029

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.

Perimeter Medical Imaging AI, Inc.

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Primary Device ID20754016215029
NIH Device Record Keycee9428c-b7ab-4c2d-a8ad-43c52c73fb89
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpecimen Immobilizer
Version Model NumberPMI010CON21
Catalog NumberASY-2600
Company DUNS204112346
Company NamePerimeter Medical Imaging AI, Inc.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com
Phone1-877-278-4614
Emailcontact@perimetermed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100754016215025 [Primary]
GS100754016215032 [Unit of Use]
GS120754016215029 [Package]
Contains: 00754016215025
Package: 10 pck consumables [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-07
Device Publish Date2021-08-30

Devices Manufactured by Perimeter Medical Imaging AI, Inc.

00754016215049 - S-Series OCT2021-12-15 The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tiss
00754016215018 - THiA2021-09-07 The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tiss
20754016215029 - Specimen Immobilizer2021-09-07The 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.
20754016215029 - Specimen Immobilizer2021-09-07 The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumabl
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