SFG Sperm CD

GUDID 00850068289523

SPECTRUM FERTILITY GROUP INC.

Assisted reproduction procedure dish

• Primary Device ID: 00850068289523
• NIH Device Record Key: 351e4fed-c4d9-4a04-8dd3-013261112c5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SFG Sperm CD
• Version Model Number: S-D-SS3
• Company DUNS: 119292307
• Company Name: SPECTRUM FERTILITY GROUP INC.
• Device Count: 6
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850068289523 [Unit of Use]
GS1	10850068289520 [Primary]

FDA Product Code

• PUD: Labware, Assisted Reproduction, Exempt

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: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [SFG Sperm CD]

• 00850068289523: S-D-SS3
• 00850068289516: S-D-SS2
• 00850068289509: S-D-SS1