Histoplex

GUDID 00840165500195

Specimen Container, 90 ml, Yellow Cap, Affixed 10% Buffered Formalin Label, Non-Sterile.

Starplex Scientific Corp.

General tissue specimen container IVD, no additive

• Primary Device ID: 00840165500195
• NIH Device Record Key: 8d7108e6-dfbc-48d1-8590-7b2ea4d5b567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histoplex
• Version Model Number: H902-FL
• Company DUNS: 859771235
• Company Name: Starplex Scientific Corp.
• Device Count: 100
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840165500188 [Unit of Use]
GS1	00840165500195 [Package]; Contains: 10840165500185; Package: [4 Units]; In Commercial Distribution
GS1	10840165500185 [Primary]

FDA Product Code

• NNI: Container, Specimen, Non-Sterile

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: 2025-06-05
• Device Publish Date: 2025-05-28

On-Brand Devices [Histoplex]

• 00840165500195: Specimen Container, 90 ml, Yellow Cap, Affixed 10% Buffered Formalin Label, Non-Sterile.
• 00840165500218: Specimen Container, 120 ml, Yellow Cap, Affixed 10% Buffered Formalin Label, Non-Sterile