SpermCryo All-round USA

GUDID 08719747531594

SpermCryo® All-round USA is a four times concentrated ready-touse HEPES buffered cryopreservation medium for freezing human sperm for further use in Assisted Reproductive Technologies (ART). SpermCryo® All-round USA is used during assisted reproductive Technology (ART) procedures of patients and couples undergoing infertility treatments.

Gynotec.B.V.

IVF medium

• Primary Device ID: 08719747531594
• NIH Device Record Key: 90f003cd-00d2-44aa-bd48-c9ac59cca81d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpermCryo All-round USA
• Version Model Number: SPCA-USA-0005
• Company DUNS: 489854382
• Company Name: Gynotec.B.V.
• 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: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719747531587 [Primary]
GS1	08719747531594 [Package]; Contains: 08719747531587; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053494

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: 2026-01-27
• Device Publish Date: 2026-01-19

On-Brand Devices [SpermCryo All-round USA]

• 08719747531617: SpermCryo® All-round USA is a four times concentrated ready-touse HEPES buffered cryopreservati
• 08719747531594: SpermCryo® All-round USA is a four times concentrated ready-touse HEPES buffered cryopreservati