Epredia

GUDID 05051663003643

SHANDON DIAGNOSTICS LIMITED

Cryostat microtome IVD

• Primary Device ID: 05051663003643
• NIH Device Record Key: 2f70d144-59a6-47ed-ad1a-09f9e5365c00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epredia
• Version Model Number: NX50 CRYOSTAR HOP110-120V
• Company DUNS: 219103512
• Company Name: SHANDON DIAGNOSTICS 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	05051663003643 [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: 2023-08-03
• Device Publish Date: 2023-07-26

On-Brand Devices [Epredia]

• 05051663003797: NX70 CRYOSTAR WITH UPBLADE HOLDER
• 05051663003780: NX70 SYSTEM WITH HOMP, 100V, 50/60HZ
• 05051663003858: NX70 SYSTEM WITH HOMVPD, 110-120V
• 05051663003841: NX70 SYSTEM WITH HOMVP, 110-120V
• 05051663003834: NX70 CRYOSTAR WITH UPBLADE HOLDER
• 05051663003827: NX70 CRYOSTAR WITH UPBLADE HOLDER
• 05051663003810: NX70 CRYOSTAR WITH UPBLADE HOLDER
• 05051663003803: NX70 CRYOSTAR WITH UPBLADE HOLDER
• 05051663005418: HM525 NX system + UV, 110-120V
• 05051663005395: HM525 NX system, 110-120V
• 05051663003650: NX50 CRYOSTAR OVP 100-120V
• 05051663003643: NX50 CRYOSTAR HOP110-120V
• 05051663003636: NX50 CRYOSTAR OP 100-120V
• 05051663003612: NX50 CRYOSTAR HOVP 110-120V
• 05051663003575: NX50 CRYOSTAR HOVP 100V
• 05051663003568: NX50 CRYOSTAR HOP 100V.
• 05051663003513: NX50 CRYOSTAR HOVPD 110-120V
• 05051663003506: NX50 CRYOSTAR OVPD 100-120V
• 05051663003490: NX50 CRYOSTAR HOPD 110-120V
• 05051663003483: NX50 OPD 100-120V
• 05051663003476: NX50 CRYOSTAR HOVPD 110V
• 05051663003469: NX50 CRYOSTAR HOPD 110V
• 05051663009386: STP 120-2
• 05051663005258: HM 355S With STS
• 05051663005241: Microtome HM 355S
• 05051663005227: HM355 S Microtome
• 05051663005203: HM340 E Microtome
• 05051663005180: HM340 E Microtome
• 05051663005166: HM325 Rotary Microtome
• 05051663005142: HM325 Microtome
• 05051663009126: HM430 Sliding Microtome
• 05051663009973: Slide Basket Transfer System
• 05051663005456: HM525 NX system+UV, 220-240V, 50HZ
• 05051663005432: HM525 NX system, 220-240V, 50Hz
• 05051663003896: NX70 CRYOSTAR WITH HOMVPD
• 05051663003889: NX70 CRYOSTAR WITH HOMVP
• 05051663517300: Revos and Excelsior accessory
• 05051663615884: Linistat Slide Stainer - Accessory
• 05051663615877: Linistat Slide Stainer - Accessory
• 05051663518017: PT Module - Accessory
• 05051663518000: Linistat Slide Stainer - Accessory
• 05051663517911: Rotary Microtome - Accessory
• 05051663517904: Rotary Microtome - Accessory
• 05051663517898: Rotary Microtome - Accessory
• 05051663517867: Paraffin Bath
• 05051663517850: STP120 Tissue Processor - Accessory
• 05051663517683: Revos Tissue Processor accessory
• 05051663517676: Slide Basket Transfer System - Accessory
• 05051663517669: Slide Basket Transfer System - Accessory
• 05051663517652: Slide Basket Transfer System - Accessory