Epredia

GUDID 05051663010306

THERMO SHANDON LIMITED

Cryostat microtome IVD

• Primary Device ID: 05051663010306
• NIH Device Record Key: 1217610b-b91a-4ea4-a2cc-fe69adaaebcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epredia
• Version Model Number: NX50 CRYOSTAR OPH
• Company DUNS: 219103512
• Company Name: THERMO SHANDON LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051663010306 [Primary]

FDA Product Code

• IDP: Microtome, Cryostat

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-23
• Device Publish Date: 2021-02-15

On-Brand Devices [Epredia]

• 05051663010238: NX50 CRYOSTAR OPHV
• 05051663010221: NX50 CRYOSTAR OPH
• 05051663010214: NX50 CRYOSTAR OPHD
• 05051663010207: NX50 CRYOSTAR OPDV
• 05051663010191: NX50 CRYOSTAR WITH HEIGHT
• 05051663010184: NX50 CRYOSTAR OPD
• 05051663010177: NX50 CRYOSTAR OPHVD
• 05051663010160: NX50 CRYOSTAR OPDV
• 05051663010153: NX50 CRYOSTAR OPHD
• 05051663010146: NX50 CRYOSTAR OPD
• 05051663010139: NX50 CRYOSTAR OPHVD
• 05051663010122: NX50 CRYOSTAR OPHD
• 05051663010115: HM 450 SLIDING MICROTOME
• 05051663010108: HM 430 SLIDING MICROTOME
• 05051663010092: HM 355S MICROTOME
• 05051663010085: HM 340 E MICROTOME
• 05051663010078: HM325 ROTARY MICROTOME
• 05051663010061: HM525 NX UV CRYOSTAT
• 05051663010054: HM525 NX CRYOSTAT
• 05051663010047: HM525 NX UV CRYOSTAT
• 05051663010030: HM525 NX CRYOSTAT
• 05051663010023: LINISTAT
• 05051663010016: LINISTAT
• 05051663009966: REVOS
• 05051663009775: CTM6
• 05051663009768: CTM6
• 05051663009751: EXCELSIOR AS
• 05051663009737: EXCELSIOR AS
• 05051663009720: GEMINI AS
• 05051663009713: GEMINI AS
• 05051663009706: GEMINI AS
• 05051663009690: GEMINI AS
• 05051663009683: EMBEDDING MODULE
• 05051663009676: EMBEDDING MODULE
• 05051663009669: COLD MODULE
• 05051663009652: COLD MODULE
• 05051663009645: COLD MODULE
• 05051663009638: HISTOSTAR
• 05051663009621: HISTOSTAR
• 05051663009614: HISTOSTAR
• 05051663009607: AUTOSTAINER 720 & PT 110V
• 05051663009591: AUTOSTAINER 720 & PT 110V
• 05051663009584: AUTOSTAINER 720 & PT 220V
• 05051663009577: AUTOSTAINER 480S PT 110V
• 05051663009560: AUTOSTAINER 480S PT 220V
• 05051663009553: AUTOSTAINER 360 & PT 110V
• 05051663009546: AUTOSTAINER 360 & PT 220V
• 05051663009539: AUTOSTAINER 720
• 05051663009522: AUTOSTAINER 720
• 05051663009515: AUTOSTAINER 480S