Leica Biosystems HIGH TRANSM. RED FOR LEICA DM

GUDID 00849832011460

Leica Biosystems HIGH TRANSM. RED FOR LEICA DM

Leica Biosystems Richmond, Inc.

Fluorescence light microscope

• Primary Device ID: 00849832011460
• NIH Device Record Key: 09ade512-5ac7-4aae-944b-a16f88fb8c7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leica Biosystems HIGH TRANSM. RED FOR LEICA DM
• Version Model Number: 232FLAL324872
• Company DUNS: 082930884
• Company Name: Leica Biosystems Richmond, Inc.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849832011460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042542

FDA Product Code

• JOY: DEVICE, AUTOMATED CELL-LOCATING

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-14

Devices Manufactured by Leica Biosystems Richmond, Inc.

• 00849832001003 - Leica Biosystems: 2025-07-31 Parafree Metal Base Molds 7 x 7 mm
• 00849832001010 - Leica Biosystems: 2025-07-31 Parafree Metal Base Molds 15 x15mm
• 00849832001027 - Leica Biosystems: 2025-07-31 Parafree Metal Base Molds 25 x 25mm
• 00849832001034 - Leica Biosystems: 2025-07-31 Parafree Metal Base Molds 30 x25mm
• 00849832001041 - Leica Biosystems: 2025-07-31 Parafree Metal Base Molds 37 x25mm
• 00849832001058 - Leica Biosystems: 2025-07-31 Parafree Disposable Base Molds 24 x 30
• 00849832003090 - Leica Biosystems: 2025-07-31 Parafree Disposable Base Molds 24 x 24
• 00849832025818 - Leica Biosystems: 2025-07-31 Parafree Base Molds 10 x10 mm