GLOW800

GUDID 07630802402615

GLOW800 - Accessory for Leica surgical operating microscope systems

Leica Microsystems (Schweiz) AG

Surgical microscope fluorescent angiography system
Primary Device ID07630802402615
NIH Device Record Keyf6bd6751-7a76-4c90-b913-56e60ff6c4e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLOW800
Version Model Number000000000010449156
Company DUNS480198725
Company NameLeica Microsystems (Schweiz) AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com
Phone+1(984)7105152
EmailIris.Pohl@leica-microsystems.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *
Special Storage Condition, SpecifyBetween 0 and 0 *

Device Identifiers

Device Issuing AgencyDevice ID
GS107630802402615 [Primary]

FDA Product Code

IZISystem, x-ray, angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-13
Device Publish Date2024-05-03

Devices Manufactured by Leica Microsystems (Schweiz) AG

07630802405906 - ARveo 8x2025-09-25 ARveo 8x stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8x
07630003501612 - M320 Optics Carrier2024-09-09 M320 Optics Carrier incl. Swing arm - for Leica surgical operating microscope systems: M320 FP12, M320 F12, M320 TP12, M320 LW12
07630802402615 - GLOW8002024-05-13GLOW800 - Accessory for Leica surgical operating microscope systems
07630802402615 - GLOW8002024-05-13 GLOW800 - Accessory for Leica surgical operating microscope systems
07630802402622 - ARveo 82024-05-13 ARveo 8 stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8
07630802403810 - MyVeo2024-05-13 MyVeo - Complete device including the Connection Hub, all Connection Cables and one MyVeo Headset
07630802403827 - MyVeo Headset2024-05-10 MyVeo Headset - additional Headset to MyVeo Connection Hub
07630003567717 - RUV800 WD1752022-08-29 RUV800 WD175 - Accessory for Leica surgical operating microscope systems
07630003567724 - Leica RUV800 WD2002022-08-29 RUV800 WD200 - Accessory for Leica surgical operating microscope systems
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.