SAGE 1-Step

GUDID 00888937029116

SAGE 1-Step with Human Serum Albumin. 10 ml

Coopersurgical, Inc.

IVF medium

• Primary Device ID: 00888937029116
• NIH Device Record Key: 348ae87b-8ba8-4832-897c-df971472c3aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAGE 1-Step
• Version Model Number: 67010010M
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937029116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133707

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-13
• Device Publish Date: 2026-02-05

On-Brand Devices [SAGE 1-Step]

• 00888937833041: Sage 1-Step GM-CSF with HSA. 3 ml
• 00888937029123: SAGE 1-Step with HSA and phenol red. 60 ml
• 00888937029116: SAGE 1-Step with Human Serum Albumin. 10 ml