Specimen Immobilizer ASY-2600

GUDID 20754016215029

Dermatological optical coherence tomography system

Primary Device ID	20754016215029
NIH Device Record Key	cee9428c-b7ab-4c2d-a8ad-43c52c73fb89
Commercial Distribution Status	In Commercial Distribution
Brand Name	Specimen Immobilizer
Version Model Number	PMI010CON21
Catalog Number	ASY-2600
Company DUNS	204112346
Company Name	Perimeter Medical Imaging AI, Inc.
Device Count	10
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00754016215025 [Primary]
GS1	00754016215032 [Unit of Use]
GS1	20754016215029 [Package] Contains: 00754016215025 Package: 10 pck consumables [10 Units] In Commercial Distribution

NQQ	System, Imaging, Optical Coherence Tomography (Oct)

Steralize Prior To Use	false
Device Is Sterile	false

00754016215049 - S-Series OCT	2021-12-15 The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tiss
00754016215018 - THiA	2021-09-07 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 Immobilizer	2021-09-07The 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 Immobilizer	2021-09-07 The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumabl