ASSY RGT DSPNR CARD BMK PREP KIT 316 10637609001

GUDID 07613336240434

Ventana Medical Systems, Inc.

Assay container IVD, single-use

• Primary Device ID: 07613336240434
• NIH Device Record Key: a82c17ae-1dfd-40c8-92fb-b303a2823cca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSY RGT DSPNR CARD BMK PREP KIT 316
• Version Model Number: 10637609001
• Catalog Number: 10637609001
• Company DUNS: 184042521
• Company Name: Ventana Medical Systems, Inc.
• 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: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336240434 [Primary]

FDA Product Code

• JRC: MICRO PIPETTE

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: 2026-03-30
• Device Publish Date: 2026-03-20

Devices Manufactured by Ventana Medical Systems, Inc.

• 07613336240281 - ASSY RGT DSPNR CARD BMK PREP KIT 301: 2026-03-30
• 07613336240298 - ASSY RGT DSPNR CARD BMK PREP KIT 302: 2026-03-30
• 07613336240304 - ASSY RGT DSPNR CARD BMK PREP KIT 303: 2026-03-30
• 07613336240311 - ASSY RGT DSPNR CARD BMK PREP KIT 304: 2026-03-30
• 07613336240328 - ASSY RGT DSPNR CARD BMK PREP KIT 305: 2026-03-30
• 07613336240335 - ASSY RGT DSPNR CARD BMK PREP KIT 306: 2026-03-30
• 07613336240342 - ASSY RGT DSPNR CARD BMK PREP KIT 307: 2026-03-30
• 07613336240359 - ASSY RGT DSPNR CARD BMK PREP KIT 308: 2026-03-30