SAGE 1-Step

GUDID 00888937803389

SAGE 1-Step with SPS and phenol red. 10 ml

Origio A/S

IVF medium

• Primary Device ID: 00888937803389
• NIH Device Record Key: 1f8304e6-f411-41ce-865d-fa54d714de23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAGE 1-Step
• Version Model Number: 67020010D
• Company DUNS: 305424269
• Company Name: Origio A/S
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937803389 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-22

On-Brand Devices [SAGE 1-Step]

• 00888937833072: SAGE 1-Step GM-CSF with SPS. 3 ml.
• 00888937833058: Sage 1-Step GM-CSF with HSA. 3 ml
• 00888937803402: SAGE 1-Step with SPS and phenol red
• 00888937803389: SAGE 1-Step with SPS and phenol red. 10 ml
• 00888937803365: SAGE 1-Step with HSA and phenol red. 60 ml
• 00888937803341: SAGE 1-Step with Human Serum Albumin. 10 ml