Epredia

GUDID 05051663009126

SHANDON DIAGNOSTICS LIMITED

Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD Sliding microtome IVD

• Primary Device ID: 05051663009126
• NIH Device Record Key: 99e7d95d-a3ce-4e2f-91c3-b596c3e65f9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epredia
• Version Model Number: HM430 Sliding Microtome
• 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	05051663009126 [Primary]

FDA Product Code

• KFL: Microtome, Sliding

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: 2023-08-10
• Device Publish Date: 2023-08-02

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